Astellas Pharma Inc. Recruit

A Message from the head of Chemical & Biological Technology Labs.

Hideto Yamaguchi

In April 2020, the Chemical & Biological Technology Labs. was established by merging the Synthetic Processes Research Laboratory, responsible for the development of synthetic processes for small molecule drugs, and the Bioprocesses Research Laboratory, responsible for the development of culture and purification processes for biopharmaceuticals such as antibody products, in order to fully realize the utilization of CMC research and development for various modalities.
The modalities covered by the Chemical & Biological Technology Labs. range from chemically synthesized compounds to fermentation products, biopharmaceutical products, and even virus-based products and cell-based products produced by inducing differentiation of stem cells. If it can become a pharmaceutical product, the Chemical & Biological Technology Labs. is in charge of the entire development of the drug substance manufacturing process. In addition, for modalities with immature drug substance manufacturing technologies such as viruses and cells, we introduce state-of-the-art robotic and digitalization technologies, and we are advancing research on the mechanization and automation of drug substance manufacturing facilities and operations.

It takes 10 years to get a drug on the market. During this period, the manufacturing process development begins with the acceptance of the manufacturing method in the early stage of research, and it requires a deep scientific understanding of the target product and manufacturing process, development of a robust process that can withstand commercial use, acquisition of regulatory approvals in each country, and technology transfer to domestic and overseas manufacturing plants. Even in the same process development, there are different challenges in each development phase, and researchers affiliated with the Chemical & Biological Technology Labs. have the opportunity to accumulate a lot of experience in pharmaceutical product manufacturing.

Global development is one of the characteristics of Astellas’drug substance process development research. Under Astellas’ vision of "On the forefront of healthcare change to turn innovative science into VALUE for patients," we continues to add companies and researchers who are at the cutting edge of science overseas to our organization. By combining our previous experience in manufacturing with advanced science, we are taking on challenges every day to bring first-in-class and unique pharmaceutical products to patients as quickly as possible.
Astellas is looking for passionate researchers who can work globally while valuing teamwork, and who can personally create their own future and innovative research areas.

Employee Q&A

I study the method for the scale-up synthesis of drug substances, which is active pharmaceutical ingredients.

Master of Molecular Pharmaceutical Science, Graduate School of Pharmaceutical Sciences
Joined the company in 2022

Honoka Teraji

• Q1What is your current job description?

  I study the method for the scale-up synthesis of drug substances, which is active pharmaceutical ingredients.

  In order to deliver pharmaceuticals to patients around the world, we must be able to scale-up synthesis of drug substances. Since the quality of pharmaceuticals directly affects the health of patients, a manufacturing method that can stably supply high-quality drug substances is necessary. In scale-up synthesis, it is also necessary to consider the environment and safety, and to aim for cost reduction.
  At the Chemical & Biological Technology Labs, we are developing manufacturing methods that enable the stable, safe, and low-cost supply of high-quality drug substances. We are responsible for work related to drug substances in a wide range of development phases, from lab-scale experiments to large scale manufacturing for commercial products and post-marketing life cycle management. In addition, we are able to be involved in operations necessary for the stable supply of drug substances, such as submitting applications to the regulatory authorities and managing starting material sources and manufacturing sites.
  I am in charge of small molecule drugs in the early stages of development, and developing manufacturing methods for the first chemical synthesis of drug candidate compounds on a kg scale. The drug substances produced will be used for formulation studies and clinical trials, so it is necessary to establish a manufacturing method that enables synthesis with a predetermined quality and schedule. Within a limited time frame, I search for appropriate routes and reaction conditions by repeating the cycle of hypothesizing, experimenting, and discussing. I also discuss with my colleague to get hints and obtain information through literature research, challenging myself to improve the manufacturing method to a high quality. When I was in university, I often thought only about the "target compound," hoping to synthesize it, but since joining the company, I have been able to think more deeply about "how to synthesize" compounds.
  I feel each job is worthwhile when I think that there are patients waiting for the drugs we synthesize.

• Q2When do you find work interesting or difficult?

  Synthesizing large quantities of drug substances is difficult, but also interesting and fulfilling work.

  I find the process of achieving scale-up synthesis both interesting and difficult. When deciding on a synthesis method in the laboratory, we consider many things. For example, the reaction conditions for high yield, whether the reaction proceeds in the same way each time, how to synthesize from even the cheapest starting materials, how to remove or reduce impurities, how to reduce the workload at the manufacturing site, and so on. There are many items to be considered, and I feel that it is difficult to choose a policy and selection for consideration. That said, I find research interesting when I can prove a hypothesis or find the cause of a problem.
  If I were to do chemical synthesis on my own, I would be limited to a few 10g scale at most. I was surprised to see how many people are involved in the safe and high-quality synthesis on the scale of several 10kg to several 100kg. For example, we work with an environmental safety team that confirms that the manufacturing process we have created is safe for operations, a quality assurance department that confirms that the quality of the drug substances can be assurance using the established manufacturing process and test methods, and the manufacturing site where is actually produced according to the manufacturing process. I feel a great sense of accomplishment when I succeed in synthesizing a large amount of drug substances as a result of our close collaboration with the relevant departments.

• Q3In your work, what challenges would you like to take on in the future?

  I would like to take on the challenge of working in a wide range of phases, from the early stages to commercial stage.

  I would like to become a process chemist with a broad perspective and would like to experience all the processes involved in the supply of drug substances. From synthesizing a small amount of a drug candidate compound to putting it on the market and managing its stable supply, I need to understand not only organic chemistry but also chemical engineering, safety engineering, application-related laws and regulations, and many other fields. Furthermore, in order to work smoothly as a team throughout the company, it is necessary to understand and consider the processes before and after my own department. Since many of the starting material manufacturers and manufacturing plants are overseas, communication in English is also important. In my second year with the company, I am still learning, but I would like to continue to take on challenges in my daily work. I believe that the environment in which I can take on the challenges of projects in various phases is only possible at the Chemical & Biological Technology Labs, which handles everything from initial development products to commercial products in one place.

• Q4What is the appeal of working at Astellas?

  I am attracted to a work environment where I can take on a variety of challenges and work easily.

  We feel that this is an attractive environment in which to work. First of all, there is an environment where you can concentrate on your experiments. We have a wide variety of equipment, reagents, and analytical instruments for the experiments we want to conduct. We can work in teams of several people to challenge new trial, and we receive support in various ways, such as the introduction of necessary equipment. In addition, there is a culture of easy communication with people in the workplace. Regardless of the year, we are able to help each other by sharing our opinions and suggestions and receiving advice on experiments. New ideas are often born out of chit-chat. It is a good work environment in terms of work-life balance. FF Day, in which finish work earlier on Fridays, has been introduced, and paid vacations are easy to take, so employees can refresh themselves regularly. Many employees work according to their life events, such as male employees taking maternity leave.
  Another major attraction of this company is that employee growth is generously supported. Rotational training, in which employees visit related departments, allows them to deepen their understanding of their work and how their own department's work is related to the processes before and after them. When I participated in training for a department that handles biopharmaceuticals in the same laboratory, it was an opportunity to deepen my understanding of biopharmaceuticals and reconsider the characteristics of small molecule pharmaceuticals. In particular, we have a significant relationship with the manufacturing plant, which synthesizes drug substrates using the manufacturing process we created, allowing us to experience the manufacturing site over a six-month period. The scale-up from the laboratory to the manufacturing site is not simply a difference in size. The perspectives that can be learned from the manufacturing site are also important for future process development, and I find it attractive to be able to experience this as training. In addition, we have other systems in place to support self-improvement, such as participation in domestic and international academic conferences and support for degree acquisition. The fact that there are many people challenging themselves to achieve their goals is a good stimulus, and I think it is an environment where we can grow together.

A day in the life of Honoka Teraji

Employee Q&A

Development of the cell culture process for antibody pharmaceuticals.

Completed Ph.D. in Computational Biology and Medical Sciences
Joined the Company in 2021.

Masaru Shimojo

• Q1What is your current job description?

  Development of the Cell Culture Process for Antibody Pharmaceuticals.

  I am working on the development of cell culture processes for the production of antibody pharmaceuticals. Pharmaceutical companies have a responsibility to consistently deliver high-quality and safe products to the many patients in need. To achieve this, it is necessary to develop a process that not only verifies the effectiveness and safety in clinical trials but also produces and supplies high-quality products. In the case of antibody pharmaceuticals, it is necessary to develop a cell culture process that maximizes the productivity of the cell line producing the antibodies and demonstrates stable quality.
  Furthermore, the developed process must not only be demonstrable at the laboratory scale but also ensure equivalent performance when scaled up to bioreactors hundreds to thousands of times larger than the laboratory scale. Therefore, we are concurrently working on various technological developments in parallel with our process development tasks, utilizing them to enhance the development of better processes and their scale-up evaluations.
  In addition, process development work is sometimes carried out in collaboration with other companies. We discuss the planning of experiments and interpretation of results needed for process development while progressing together. As we often collaborate with overseas companies, there are opportunities to engage in global work, which requires proficiency in English for effective communication.

• Q2When do you find work interesting or difficult?

  The Fascination of Encountering "New Things" and the Challenge of Solving Them

  What I find interesting about this job is that I encounter a lot of "new things." In the field of biopharmaceuticals, there are many "new things" such as the process development for new antibody molecules or New Modalities, advancements in technology, the introduction of new equipment, and the absorption of new knowledge. However, for every encounter with something "new things," an equal number of "challenges" arise. "Challenges" like developing the suitable processes for new molecules/New Modalities and establishing the operational systems to ensure that newly introduced equipment is accessible to everyone, and more, also emerge in abundance, and more, also emerge in abundance. It can be difficult to solve these "challenges" on my own, but through discussions and verifications with the team, we can lead to new discoveries and find solutions, which in turn adds to the excitement. I consider myself fortunate to be able to work at Astellas, where such an environment exists, as I have a curious and inquisitive nature.

• Q3In your work, what challenges would you like to take on in the future?

  Reliable and Swift Process Development and Challenging Technological Advancements

  In pharmaceutical process development, I understand that ensuring reliability in the work is crucial, as it is necessary to develop a process for producing active pharmaceutical ingredients stably without causing delays to the schedule. In recent years, Astellas has seen an increase in achievements in process development for antibody pharmaceuticals, and a platform for process development is beginning to take shape. However, many specialized antibodies like bispecific antibodies come into play on the development stage. It becomes necessary to optimize the process for each molecule. Therefore, I aim to leverage scientific knowledge and experience for any type of molecule, in order to swiftly develop a reliable process.
  Additionally, new technologies in the field of biopharmaceuticals are advancing at an astounding pace. To avoid falling behind in the industry, it's crucial to constantly monitor new technologies, evaluate their potential usefulness for our company early on, and take in those valuable technologies. While implementing such technologies may take time, I consider it a highly rewarding endeavor, as it could potentially elevate our company's technological capabilities. I'm eager to take on these challenges actively.

• Q4What is the appeal of working at Astellas?

  Open and Transparent Work Culture

  Even as a young professional, I feel comfortable expressing my opinions in this open and communicative work environment. As a result, each individual is able to showcase their unique personalities and expertise while collaborating effectively on tasks. In meetings, there is active exchange of ideas, regardless of whether someone is a young professional or a seasoned veteran.
  
  Furthermore, I perceive that young professionals are provided with numerous opportunities for growth, such as participation in conferences. While the shift to online participation has increased due to the impact of COVID-19, there are still opportunities to attend international conferences locally, allowing us to stay updated with the cutting-edge developments in the industry. If there is an interest in new technologies from other companies, regardless of one's seniority, arranging meetings or attending seminars is possible, facilitating information gathering.
  
  Moreover, the company as a whole is dedicated to promoting work-life balance, including both work and parenting. In my department, it is relatively easy to take maternity or paternity leave, and many individuals, regardless of gender, have taken advantage of this opportunity. I myself took paternity leave when my first child was born.

A day in the life of Masaru Shimojo

A Message from the head of Pharmaceutical Research and Technology Labs

Hiroyuki Kojima

New compounds with pharmacological activity will finally become pharmaceutical products (medicines) that can be administered to patients through pharmaceutical research. There are a variety of formulations, including oral formulations such as tablets and capsules, injectables, transdermal, and inhalation, etc. In addition, there are a lot of technologies that can be incorporated into each formulation to optimize/maximize treatment effects. For this reason, researchers with knowledge and technical skills not only in pharmacy but also in physical chemistry, biology, and mechanical engineering have been working at Pharmaceutical Research and Technology Labs. The products developed by our researchers via formulation development, process design, and packaging and device development are clinically used to treat patients worldwide. In addition to small molecules and antibodies, we have recently been focusing on pharmaceutical research of cell-based and mRNA LNP products, as well as development of apps, formulation design AI, Dx, drug delivery systems and new pharmaceutical technologies to maximize the value of drug product.
As one of the research areas closest to patients, clinical, and pharmaceutical products, we are honored and proud of our pharmaceutical research that generates products in all modalities. In order to deliver higher-value pharmaceutical products to patients around the world as soon as possible, why not work with us at the "Pharmaceutical Research and Technology Labs" where we work hard on research every day in cooperation with not only domestic but also overseas bases such as Chicago/Boston in the US and Netherland?

Employee Q&A

We research to find the optimal drug delivery system (DDS) for "drug seeds" having pharmacological effects for enhancing the delivering value for patients.

Master of Pharmacy，School of Pharmaceutical Sciences (6-year program)
Joined the company in 2020

Ayaka Masuda

• Q1What is your current job description?

  We research to find the optimal drug delivery system (DDS) for "drug seeds" having pharmacological effects for enhancing the delivering value for patients.

  “Drug seeds” (active ingredients or drug substances) include various modalities such as small molecules, antibodies, nucleic acids, and cells etc. Pharmaceutical research is converting them into “drug products” that can be administered to patients. In the research area, DDS is a technology to control movement of the drug substances in the body after administration. To improve drug efficacy, reduce side effects, and/or improve patients convenience, our challenge is to create drug products for delivery of the optimal amount of drug substances for the appropriate time to the best sites in the body where the drugs perform their efficacy.
  
  I’m working at DDS Laboratory. We investigate and select the optimal DDS technologies for each modality and issues, when it’s difficult to develop the "drug seeds" to drug products due to their insufficient efficacy and/or extensive side effects etc. If there is no suitable technology, we investigate and create a new pharmaceutical technologies, i.e., a novel invention. We hear voices and needs of patients and medical professionals from other departments members in such as sales reps, and we confirm what kind of formulation is required.
  We prepare and evaluate prototype DDS formulations in vitro and in vivo to confirm their performance. These evaluations are conducted by ourselves, and sometimes by research division members with specific techniques. After execution of cycles of the studies to improve formulations performance, we file formulation patents application if the concept of DDS technology is confirmed.
  To realize the prototype DDS formulation into “drug products” having higher quality, stable manufacturing, we relay the baton to researchers of Formulation Design Laboratory and CMC Research. They investigate optimization of formulation compositions, such as types and amounts of excipients, and manufacture investigational drugs for clinical trials. To establish stable and efficient manufacturing process for the high-quality “drug products” with low cost, researchers at Process Technology Laboratory optimize the process, and transfer the technology to global manufacturing sites. To protects the quality of “drug products” during long-term storage and transportation, researchers at Packaging and Devices Laboratory design the optimal packaging which is easy to use for patients and medical professionals. In recent years, we also develop administration devices for easy dosing and medical apps (Software as Medical Device).
  
  In addition to experiments and collaboration with various experts, search and understanding of the world's cutting-edge DDS technologies are also important aspects for us. Reading the latest and cutting-edge papers and patents enables us to select the most suitable DDS technology for each modality and issue and promote development of drug products.

• Q2When do you find work interesting or difficult?

  Research often does not progress as expected, but I feel pleasure of being able to quickly deliver high value to patients, and scientific interesting when we obtain experimental data which contribute to projects promotion even a little through trial and error with team members.
  
  In some projects, we discuss with overseas members in English. Previously, when I proposed a future plan based on our data, miscommunication prevented smooth discussion and obtaining consensus. Therefore, I obtained additional data, improved phrasing and expression, and finally, I could get consensus on our idea and felt a sense of accomplishment.

• Q3In your work, what challenges would you like to take on in the future?

  I would like to try formulation development for various “drug seeds” and deliver the value to patients.

  Issues to be solved and the suitable formulations depend on the modality of “drug seeds''. Content of investigation and collaboration partners also differ between drug discovery projects in early stage and development of additional dosage forms for launched products as LCM (life cycle management). In order to make drug products of the various “drug seeds” launched, I intend to continue to challenge technology search and formulation preparation, accumulate knowledge and experience, and would like to contribute to “value for patients'' as a formulation researcher.
  
  Moreover, expertise in many fields is essential to promote projects. For commercialization of products, it’s extremely important to communicate with a variety of key stakeholders having expertise such as pharmacology, synthesis, pharmacokinetics, safety, regulation, stability, equipment etc.. Mutual understanding is also a key for success in collaboration with academia and startups.
  I would like to learn more knowledge from my seniors, expand my views as a pharmaceutical scientist, and continue to take on challenges together with colleague teams.

• Q4What is the appeal of working at Astellas?

  We can feel our own growth while receiving cooperation and support from many colleague.

  As one of attractive points in working with Astellas, we, young researchers, can be assigned to a responsible researcher of a project, receive generous support from our senior colleagues, and grow ourselves through the projects. In organizational culture of Astellas, employees share own thoughts and ideas and respect each other, regardless of age or department.
  In my second year working in Astellas, I was assigned as a responsible researcher of a project for the first time, and I didn't know what/how to proceed with the project and how to collaborate with colleague etc. At that time, I received many advice and suggestions from my seniors and team members, and tried candidate ways by myself, and gradually I was able to proceed the project more smoothly. Even now, I sometimes consult with my seniors when I don’t have confidence in selection of options. Senior colleague always take time to listen to my opinions and give me thoughtful advice even in their busy time. I believe, another attractive point in working with Astellas is that we can respect many seniors not only as a researcher, but also as a person.
  
  Additionally, Astellas has many programs for employee’s growth. For example, young colleague, called mentors, teach the basic social manners and company rules to new commers (one and a half years after joining Astellas). To encourage growth as scientists, there are several supporting systems such as obtaining Ph.D. degrees, participation in academic conferences, and visiting scholars at foreign academia.
  I will continue to grow myself day by day so that I can become a reliable senior for my juniors.

An example of my daily schedule

* Affiliation at the time of posting.

Message from Vice President

Kei Motonaga

The function and quality of a pharmaceutical product are not simply expressed by the analytical results of the final product, but are created through a research process that determines relevant properties throughout the research and development of the drug substance and drug product, and leads to more sophisticated process establishment, formulation design, and packaging design. The name "Analytical Research Labs." is derived from the concept of "scientifically exploring the critical properties of products".
The scope of our work ranges from the initial development stage to the end of the product's lifecycle. The countries where applications are filed and the production sites are increasingly globalized. Research and development (R&D) targets are not limited to active ingredients such as viruses, cells, antibodies, and chemically synthesized pharmaceuticals, or to their formulations themselves, but also include pharmaceutical excipients such as functional polymers, which require various characterization technologies as formulation and device functionnalites become more and more sophisticated. The Analytical Research Labs. is open to all researchers, regardless of their field of expertise, who wish to find their own dream in bringing valuable medicines to the patients in the world.

Employee Q&A

I develop analytical methods to evaluate the quality of drug products of small molecule and conduct research to understand their physico-chemical properties.

Joined in 2021, graduate of master's degree at the Graduate School of Medical and Pharmaceutical Sciences (Pharmaceutical Sciences)

Hitomi Okada

• Q1What is your current job?

  In order to deliver highly functional, high-quality drugs to patients as quickly and stably as possible, I am engaged in the development of test methods and research on the physico-chemical properties of drug products.

  Proper design and manufacturing of drugs and assurance of their quality are essential to deliver safe and reliable drugs to patients. In the Analytical Research Labs., we mainly develop test methods to evaluate the quality of drugs (drug substances and drug products) and conduct research to understand their physico-chemical properties.
  I am currently in charge of the development of test methods and research on the physico-chemical properties of small molecule drug products (formulated products for administration to patients) under development.
  In the test method development, we control the quality of drug products by setting test procedures and acceptance criteria from the development stage when clinical trials are initiated. As the development progresses, the level of control is increased to achieve higher quality in terms of efficacy, safety, and stable supply. A drug product is not a single component of the drug substance (the active ingredient of a drug), but a mixture including excipients. Drug product-specific impurities resulting from reactions with excipients and packaging can be present in the drug product. Furthermore, a single drug substance can be used to design drug products with various contents, dosage forms, and formulations. Therefore, when developing a test method for a drug product, sample preparation methods and analytical conditions must be optimized according to the properties of the drug product, and a wide range of test items must be set.
  In physico-chemical properties research, we evaluate the functionality of formulations, such as improvement in stability and dissolution by excipients, and investigate the causes of quality issues. The information obtained from the physico-chemical properties research is shared with members responsible for formulation design and used to develop and improve formulations and manufacturing processes, thereby contributing to Astellas’s entire process of creating drug product from the quality aspect.
  In addition, I prepare documents for clinical trial application in various countries, transfer test method technology and outsource stability tests to analytical sites inside and outside the company, and conduct basic research for understanding drug product properties and exploring new technologies.

• Q2When do you find your work interesting or difficult?

  I find it interesting to come into contact with a wide variety of knowledge and technologies, and to utilize the skills and know-how I have acquired to move forward with my work.

  For the development of a single drug product, members with various backgrounds, including synthesis and analysis of drug substances, formulation and process design, work together. Furthermore, a wide range of technologies are used. In order to correctly understand and evaluate the quality of a drug product, not only knowledge of the physico-chemical properties analysis of the drug product and instrumental analysis techniques, but also knowledge in other specialized areas is necessary. Since joining the company, I have been given opportunities to develop various test methods, conduct research on physico-chemical properties, and attend meetings and training sessions with members from other specialized fields. Through these opportunities I feel that my knowledge and skills are expanding every day. I feel a sense of accomplishment when I am able to develop and present optimal analytical methods in accordance with the characteristics of the analyte based on my accumulated knowledge and experience.
  In some cases, problems with test methods and analysis, such as a lack of reproducibility or observation of outliers, could occur. It is sometimes difficult to solve the problems because the root cause could not be immediately identified. Even in such situations, I find it interesting to gain new insights through discussions with my seniors, information gathering from other departments, repeated experiments, and trial-and-error. When we reach a solution, I feel a great sense of accomplishment, and at the same time, I feel a sense of growth, which is very rewarding.
  In order to work efficiently and effectively, knowledge of pharmaceutical regulations, knowledge of statistics and data science for analysis, and an understanding of the needs of analytical sites for technology transfer and outsourcing are also required. I feel that I have a lot to learn in my research life, and I am motivated every day by the fact that every single task I accomplish with the know-how I have gained is connected to "delivering drugs to patients".

• Q3What is something you would like to challenge yourself in the future at work?

  I would like to acquire a wide range of expertise centered on physico-chemical properties analysis, and to be able to lead the project in cooperation with people who are active in other fields.

  The work of the Analytical Research Labs. involves various processes from the development stage to post-launch. Currently, I am involved in the project of small molecule solid drug product in the early stages of development. In future, I would like to enhance my expertise in physico-chemical property analysis while gaining experience by challenging myself at various stages and analytical target. Like my seniors, I would like to be able to proactively lead the projects and contribute to the other departments from the viewpoint of physico-chemical property analysis.
  In addition to enhancing my expertise, I would like to take on challenges of introducing new technologies and proposing new solutions by expanding my knowledge and skills in other related fields and refining my imagination, creativity, and ability to think critically. I would also like to deepen my understanding of the work in different fields and contribute to promoting effective collaboration that takes advantage of each other's strengths.
  Furthermore, I am currently actively involved in joint research with other research institutions and participating in academic conferences, which gives me many opportunities to look outside the company. My dream is to continue to participate not only in internal but also external activities and eventually become a researcher who can contribute to the pharmaceutical industry as a whole through physico-chemical property analysis.

• Q4What attracts you to working at Astellas?

  I am attracted to the environment where I can grow and take on challenges.

  Astellas has a culture that respects diversity and individual personality, and there are people with various backgrounds, specialties, and careers inside and outside the research laboratories. Moreover, as a global pharmaceutical company, Astellas has many relationships with people from overseas. In e-mails and meetings, we have lively discussions from various perspectives. I feel that I am inspired and broadening my perspective in the global stage. Another attractive aspect is the opportunity for employees to share and enhance each other's knowledge, experience, and strengths through work-related study sessions and debriefing sessions. Furthermore, the company values and respects the opinions of young employees. We are blessed with an environment where young employees are entrusted with important work and encouraged to actively take on new challenges.
  In the Analytical Reserach Labs, we have working team (WT) activities to conduct basic research for a deeper understanding of physico-chemical properties and to develop technologies to solve common issues among new drug development projects. I have participated in several WT activities. One of the attractive points of WT activities is that there are opportunities for growth as a researcher, where we can try the development and acquisition of new technologies based on our own ideas without being bound by precedents.

A Day in the work of Hitomi Okada

Employee Q&A

I develop analytical methods to evaluate the quality of biopharmaceuticals and conduct research to understand their physical properties.

Graduate School of Pharmaceutical Sciences, Division of Bioinformatics and Chemical Genomics, Master's Degree, Joined the company in 2020

Shintaro Yamane

• Q1What is your current work?

  I am engaged in the development of analytical methods for evaluating the quality of drugs and research to understand their physical properties.

  I am mainly engaged in the development of analytical methods and research on physical properties related to the evaluation of biological activity of antibody drugs under development. I am developing analytical methods to evaluate the quality of developed antibodies based on the mechanism of action, such as the binding between antibodies and antigens, and the signal transduction reaction associated with the binding. We use various methods such as ELISA, flow cytometry, and reporter gene assays. We are working on understanding the mechanism of action and examining the test conditions in order to develop analytical methods that can correctly and stably evaluate the activity. The analytical methods we develop are used as part of quality testing to ensure that the manufactured drug product meets the desired quality.
  In addition, I conduct research to understand the properties and characteristics of developed antibodies as part of our physical properties research. Analysis of the structure of developed antibodies, stress-induced structural changes, and the correlation between such structural changes and biological activity are analyzed to gain a better understanding of developed antibodies, to select important parameters for quality control, and to provide justifications to pharmaceutical regulatory authorities. The research is carried out in conjunction with structural evaluation information obtained by HPLC and mass spectrometry (MS) at the same laboratory, so a wide range of knowledge is required. I think that elucidating physical properties based on various data is a very interesting part of the research. Of course, collaboration with other laboratories is also indispensable in understanding physical properties. The data on the physical properties of developed products obtained from the manufacturing process research conducted by the Chemical & Biological Technology Research Laboratory and the formulation research conducted by the Pharmaceutical Research & Technology Laboratories is valuable information that cannot be obtained by the Analytical Research Labs. alone. I analyze samples produced in the research process at each laboratory to obtain data on physical properties and provide the analysis results for each laboratory to promote research at each laboratory from the viewpoint of physical properties.

• Q2When do you find your work interesting or challenging?

  The process of developing robust analytical methods is very difficult and interesting.

  The various analytical methods we develop at our laboratory are used for long-lasting quality testing at manufacturing plants in Japan and overseas. Therefore, they must be robust analytical methods that can evaluate the quality of pharmaceuticals at a certain level regardless of the testing site or the analyst. When developing an analytical method, we investigate factors that may affect robustness, such as the source and lot-to-lot difference of reagents and the manufacturer and model number of analytical equipment, in addition to the operating procedures, analysts, and testing sites, to optimize the testing conditions. In particular, it is very difficult to obtain stable data for cell-based test methods because the analytical results may vary due to changes in cell conditions caused by slight changes in culture conditions or differences in passage number. For this reason, I feel a truly great sense of accomplishment when I understand the characteristics of an analytical method and complete a robust test method after much trial and error.
  Another attractive point is that the work of the Analytical Research Labs. is very broad. In addition to the microplate reader and flow cytometer that I am currently using, there are HPLC, GC (and other chromatographic instruments), MS, NMR, DSC, X-ray equipment, and etc. When I was a student, I mainly conducted bioactivity evaluations using cells, but since joining the company, I have also been conducting analytical method development using HPLC, MS and other instruments that I have never used before, so I am learning new fields through work.
  In addition to experimental work, we also handle regulatory affairs application and transfer analytical method technology to domestic and overseas testing sites, so I find it very interesting and challenging to work at the Analytical Research Labs., where I am constantly learning new knowledge and technologies. By learning new fields, I am able to gain a deeper understanding of drug development, which always keeps my days fresh and enjoyable. Of course, when learning a new field, I can take on the challenge without worry as my senior experts provide detailed guidance.

• Q3What would you like to challenge yourself in the future at work?

  As an analytical specialist, I would like to be able to lead development projects.

  As mentioned above, the work of the Analytical Research Labs. requires a wide range of skills, including analytical method development, physical properties research and pharmaceutical applications. Therefore, my daily work is a series of challenges. In the future, I would like to acquire a wide range of know-how in various fields by accumulating these daily experiences, and to be able to lead projects as an expert in analysis. In addition, as a project leader, I would like to contribute to the stable supply of safe and trusted drugs by collaborating with various departments within our company and with manufacturing and testing companies in Japan and overseas. Although I am still a novice in every field, I feel that I am growing step by step as I gradually gain experience in developing various types of test methods, acquiring data on physical properties, and preparing regulatory applications. I would like to continue to take on new challenges and continue to grow.

• Q4What is the attraction of working at Astellas?

  It is the excellent training system and growth support for employees.

  We have a mentor system in which you work together with senior employees for the first year and a half after joining our company. They are always available for consultation, so you can work with peace of mind. Of course, other than the mentors, all senior employees are also kind enough to teach you. During discussions, they are always willing to treat each other as equals as researchers.
  Astellas is a "treasure house" of experts in various fields, so to speak, and I feel that it is an environment in which it is easy to take on challenges in new fields.
  The Analytical Research Labs. is eager to acquire new technologies and research methods, and even young employees are given opportunities to actively take on new challenges. Since my third year with the company, I have joined a new technology development team on a voluntary basis, in addition to my work on development projects, and am working on the establishment of a test method to evaluate immunogenicity which is related to the safety of drugs.
  There are also various other opportunities for businessperson to obtain doctoral degrees, study abroad or be posted overseas. The will to grow with the company as well as yourself is respected, and your supervisor actively encourages you to do so.
  I feel that Analytical Research Labs. has a particularly good support system. The phrase that left the greatest impression on me during my job search was, "Analytical Research Labs. is a department that values human resources."In fact, few people have the experience in the development of high-precision analytical methods, extensive evaluation of physical properties and pharmaceutical application work that is performed at Analytical Research Labs. during their university days. For this reason, the department as a whole focuses on "nurturing employees," which I feel leads to the enhancement of training programs and growth support.
  
  I am also attracted to the fact that I can grow on a global stage. Astellas has R&D and production sites in Japan and overseas. The projects I am currently in charge of are all global development products, and I sometimes have meetings with overseas representatives in English. In order to obtain regulatory approval in various countries, we file regulatory applications in accordance with country-specific regulations. I feel that the appeal of working at Astellas is that I can broaden my horizons through this kind of work in the global arena.

A Day in the work of Shintaro Yamane

A Message from the Group Leader

Hideyuki Tomoda

When you hear the word "engineering" in a pharmaceutical company, few people have an immediate image of it.The main task of the Engineering Group is to create "research facilities and plants where pharmaceutical products are manufactured." However, we do not draw plans or operate machinery.Our work is to clearly requirements and functions that research facilities, plants/factories, various equipment and systems,need to have installed, and after communicating and discussing these with expert equipment manufacturers and engineering companies, we put the requirements into practice. In general, equipment manufacturers complete their tasks after they have delivered the equipment and confirmed normal operations, and engineering companies complete their tasks after the plant is completed and handover is complete. From there,This is the most important and rewarding part of our work.This is because it is only often possible to confirm whether products are being manufactured at the quality required by users, whether there are any issues with workability and the flow of people and products, etc., after these have been put into operation. As an engineer, it is a great pleasure to see the equipment working as originally intended and to see our users happy. To this end, it is important that we ensure we have an understanding of the intentions of researchers and plant staff, who are our users, and integrate them into equipment/facility requirements. This work can be compared to an interpreter in the sense of translating scientific knowledge into engineering knowledge. We strive to be good translators every day.

The expertise required in engineering is wide-ranging.The basic focus is on construction, air conditioning, electricity,hygiene, and utilities, etc. In the development of new technologies, various specialties are required from perspectives other than facilities, such as considering the products, substances, and handling.As a result, we have engibeers with diverse background and expertise.Work is assigned in accordance with skills: first introducing small equipment, then building a mid-size manufacturing line, and then a large plant.Due to the frequent regulation changes and requirements, we share what we do not know and work together to grow, regardless of age or career, and we work to grow together.In addition to work at our domestic plants and laboratories,we are also in charge of the work at overseas plants. There are also opportunities to play an active role globally. Join us in an engineering group that contributes to the health of people around the world through our engineering knowledge.

Employee Q&A

Master of Process Engineering, Molecular Chemistry and Engineering Course, Graduate School of Chemical Sciences and Engineering
Joined the company in 2017

Natsumi Hasegawa

• Q1What is your current job description?

  The main missions of the Pharmaceutical Technology Division include "transforming the drug seeds discovered by the drug discovery research division into a form that is available for patients to take," "ensuring a stable supply of medications is available for patients to take," and "building the technical infrastructure to support the various forms of treatment that will be developed in the future."

  Within this scope, the Engineering Group is contributing to the achievement of the Pharmaceutical Technology Division’s mission by installing equipment for manufacturing investigational products to confirm the efficacy and safety of the pharmaceutical products and commercial pharmaceutical products that can be prescribed at pharmacies and hospitals, working on construction projects at plants, research laboratories, and other facilities to manufacture pharmaceutical products, and developing new technologies to improve the quality and manufacturing efficiency of pharmaceutical products. In particular, these days the speed of technological innovation, such as the use of new therapies and new modalities, is accelerating, so it is necessary to establish appropriate facilities and technologies. We work in collaboration with individuals with a wide range of expertise.
  The main work I am currently involved in is building a line for manufacturing injectable formulations for clinical trials, which is designing, verifying the operation, and adopting manufacturing equipment. When designing equipment specifications, we work in collaboration with individuals within and outside the company. Since the facility design phase has been advancing recently, we received plans from equipment manufacturers reflecting the contents of discussions to date, and are proceeding with further discussions.

• Q2When do you find work interesting or difficult?

  I find it both interesting and challenging when it comes to needing to collaborate with individuals from a broad range of departments within and outside the company, and when it comes to needing to have broader knowledge.

  As for those involved in our work, we work with many parties outside the company, including construction companies and various equipment manufacturers and, within the company, we work with various divisions including the research, procurement, and manufacturing divisions. During this process, we determine the specifications of the equipment to be installed, but there are times when opinions conflict and discussions do not proceed as well as we would like, so I feel that there are some difficulties as a coordinator. On the other hand, while hearing the opinions of various individuals, I also have the opportunity to come into contact with ideas and knowledge that I could not come up with, so I often find it interesting.
  In addition, in terms of the knowledge required for our work, it is necessary to make use of a lot of knowledge and experience, such as various regulations and understanding the specifications of equipment to be introduced, even in a single project. Furthermore, there are various matters that need to be considered because, in addition to the differences of regulations in each country, there are manufacturing facilities, utility facilities, and system equipment that need to be introduced, and it is also necessary to clarify facility specifications for buildings, air conditioning, electricity, etc. Moreover, I feel that there is no end to what we need to learn because we manufacture different products, such as drug substances and drug products (oral solid dosages, injectable formulations, etc.), depending on the manufacturing site. It takes energy to fight this, but I also find it interesting to be exposed to new things.

• Q3In your work, what challenges would you like to take on in the future?

  What I would like to do in the future is learn about forms of pharmaceutical products and treatments that are different from those used in the past, and participate in construction projects in different phases.

  For the former, the manufacturing process of drug products can be roughly divided into two processes: the drug substance process for mass production of drug seeds, and the formulation process for converting the drug substance into the form of the drug product. So far, I have been involved in the manufacturing process for commercial tablets of the drug product, and the manufacturing process for injectable formulations for clinical trials. On the other hand, as an area where I have no experience, I would like to take on the challenge of constructing manufacturing facilities for new modalities, including cell preparations. In the Engineering Group, there are opportunities to take on a wide range of tasks, and it is an environment that makes it easy to take on challenges.
  Also, in a construction project, after the concept of the facility to be constructed is determined, the basic design is devised, and then the detailed facility and equipment specifications are established. In the past, I have often been assigned to projects after the completion of the concept design of the project, so I also want to be involved in the project from an earlier stage.

• Q4What is the appeal of working at Astellas?

  The attractive points of working at Astellas are that through building a pharmaceutical manufacturing facility, I am able to contribute to the health of many patients and be involved in the large scale of work.

  Astellas' management philosophy is to contribute to the health of people around the world. I rarely have the opportunity to interact directly with patients, but I do feel that my work is significantly contributing to the health of people around the world. Also, the project that I am currently involved in is a project for which a budget of approximately 18 billion yen is being invested in conjunction with the commercial drug manufacturing line that is ongoing at the same time, and thus, I feel that I have been able to be involved in large-scale work from an early age in terms of costs.
  In the department where I currently work, including for the current project, there is a tendency for young employees to actively take on important tasks, and I find it appealing to be able to experience growth. In actuality, before I was involved in building the current injectable formulation line, I had the opportunity to travel on a long-term business trip to the site in Toyama Prefecture for half a year and acquire the skills to manufacture sterile products.

A day in the life of Natsumi Hasegawa

* Affiliation at the time of posting.

Employee Q&A

Master of Bioengineering, Mechanical Science and Bioengineering Course, Graduate School of Engineering Sience
Joined the company in 2019

Masaki Taneo

• Q1What is your current job description?

  In my current role, my primary focus is on enhancing the quality and efficiency of drug manufacturing by utilizing the latest technologies such as AI, XR, RFID, biometrics, and robotics.

  Since joining the company, I've been primarily involved in technical development, collaborating with various departments in the pharmaceutical technology sector to explore the feasibility of implementing these technologies in drug manufacturing processes. This encompasses a wide range of activities beyond pharmaceutical production itself, including maintenance, technology transfer, inventory management, access control, and laboratory research.
  The pharmaceutical industry is often said to lag behind other industries in the adoption of new technologies due to the high demand for safety in providing products that involve human lives, and the strict rules that must be adhered to in drug development. Within such constraints, there is a strong demand for agility and flexibility to quickly verify the effectiveness of new technologies and proceed with their implementation to the extent possible.
  Currently, one of my key projects involves validation of AI predictive maintenance system.This system utilizes AI to detect abnormalities in equipment in advance, using data collected from the equipment to conduct machine learning and verify whether past abnormalities could have been predicted. We're working on this with a focus on eliminating sudden equipment failures, contributing to the VALUE for patients by ensuring a stable supply of medications. In addition, we regularly participate in exhibitions to collect new technical information.

• Q2When do you find work interesting or difficult?

  I find it both interesting and challenging because I have to collaborate with a diverse array of people across various departments, both internally and externally, and because of the significant flexibility in my role.

  Especially when I meet with manufacturers who own new technologies, I often find it challenging to realize that assumptions one party makes might not align with the other's.
  Moreover, technology development involves a lot of flexibility, requiring individuals to set their own criteria for verification and final goals. I find it interesting to have some degree of discretion in approaching tasks, but at the same time, I feel the difficulty in setting goals during the early stages of projects is crucial.

• Q3In your work, what challenges would you like to take on in the future?

  What I would like to try in the future is participating in construction projects.

  Since joining the company, I have mainly been engaged in technology development work, partly because it was my wish.As for engineering projects, I have only been in charge of basic design work for equipment introduction and renovation projects that do not involve development elements, and I have no experience in actually building buildings or conducting renovation work. Therefore, I would like to gain experience in engineering work at the construction stage in the future.This is because as we proceed with technology development work, engineering knowledge and experience are often required, and I feel that experience in both, rather than one or the other, is necessary. In particular, the launch of a new building can be properly called "manufacturing" because it visibly creates something from nothing. If I have the opportunity, I would like to participate in the project to launch the new building.

• Q4What is the appeal of working at Astellas?

  In my current department, younger employees are often given significant responsibilities early on. In my second year, I took the lead on renovation planning and basic design for a section of our investigational drug building. By my third year, I was managing multiple projects related to new technology development, collaborating across departments. Although I had senior colleagues and supervisors for guidance, I primarily managed these projects independently, handling everything from scheduling to implementation. This allowed me to gain diverse experiences and feel a strong sense of personal growth. Another aspect of Astellas that I find appealing is its culture of embracing challenges company-wide

A day in the life of Masaki Taneo

* Affiliation at the time of posting.

• Q1What is your current job description?

  In the Technical Development Section, to which I belong, we are engaged in the stable supply of antibody drugs and the examination and improvement of manufacturing procedures at the actual production scale. Currently, I am handling two products: an intermediate product of PADCEV, which is designated as a breakthrough therapy by the FDA, and zolvetuximab, which is in the Phase III clinical trial stage. In my first year with the company, there was an FDA inspection of PADCEV. I was able to experience firsthand the importance of social responsibility and the patients that await us beyond our day-to-day work. By my third year, I was involved in a variety of tasks, including the start-up of a new Astellas manufacturing facility, the introduction of zolvetuximab into the new facility, and the scale-up of PADCEV production as it continued to increase. Now, in my fourth year with the company, I have increased my skills and knowledge necessary for antibody production, and I feel that I am contributing to the stable production of high-quality drugs to deliver them to patients around the world who are waiting for them

• Q2When do you find work interesting or difficult?

  I feel fun and a sense of accomplishment when I face a difficult problem and clear it with a method that has no track record so far. The global COVID-19 epidemic has dramatically changed the environment surrounding pharmaceutical manufacturing, creating many challenges. As a result of tackling one of the issues, we adopted a new policy and solved the issue caused by COVID-19. On top of that, we were able to introduce the best system with lower costs than before. In the process of solving problems, it is essential to collaborate not only with our own department, but also with other departments and outside the company that we usually have little involvement with. However, I still vividly remember the moment when the initiative took shape, I was overwhelmed with joy.

• Q3In your work, what challenges would you like to take on in the future?

  Based on the skills and knowledge I have acquired through the stable production of PADCEV intermediates and the development of commercial manufacturing processes for zolbetuximab drug substance, I will develop and strengthen commercial manufacturing processes for new modalities such as cell therapy. I would like to work as a biopharmaceutical professional.

• Q4What attracted you to work at Astellas?

  The great attraction of working at Astellas is the people. Delivering a single drug to patients involves more people than you might imagine, including research, development, manufacturing, and sales departments. In order to deliver drugs to patients more quickly, collaboration with various people is essential. I empathized with the atmosphere that the senior who was in charge of the company information session introduced the workplace lively, and I wanted to work at Astellas. When I actually joined the company, that intuition was correct. Of course, I had the cooperation of everyone in other departments when I was solving the aforementioned issues, but I am also very grateful to my boss, who encouraged me to grow while maintaining an appropriate sense of distance and correcting my trajectory as necessary. I'm here.

A day in the life of Taku Shibuya

* Affiliation at the time of posting.

Employee Q&A

We improve the aseptic control necessary for the production of injectable pharmaceutical products on a daily basis, manufacture investigational products, and establish manufacturing for new pharmaceutical products.

Pharmaceutical (Sterile) Manufacturing Engineering
Graduated from the Department of Pharmacy
Joined the company in 2019

Megumi Tamura

• Q1What is your current job description?

  We improve the aseptic control necessary for the production of injectable pharmaceutical products on a daily basis, manufacture investigational products, and establish manufacturing for new pharmaceutical products.

  I am in the investigational product department of the plant and am involved in a project to establish manufacturing for a new product.
  
  Recently, I have been investigating the sterilization of various materials necessary for the production of new products in the project to establish manufacturing for a new pharmaceutical product. For example, in order to determine the sterilization conditions for rubber stoppers, the first task is to verify whether sterilization can be performed with the same operational program as before, and to verify whether there is any change in the quality of rubber stoppers before and after sterilization. Since the establishment of manufacturing for a new pharmaceutical product will be the basis of manufacturing that will continue for many years to come, it is necessary to examine this from a more fundamental and broader perspective, such as whether existing processes and process control values were appropriate in the first place, even if the results were within acceptable limits. Also, once a procedure is established, it is difficult to change it; thus, one of the tasks is to identify issues as much as possible and propose improvements at the evaluation stage.
  
  It is also important to comply with the increasingly stringent regulatory requirements of each country. For example, although regulations for data integrity (established to prevent falsification or forgery of data) have become more stringent recently, it is not practical to keep updating/upgrading all manufacturing equipment, even if these regulations can be easily met through updates of the manufacturing equipment. Thus, we must consider how we can make up for the portion that cannot be covered by hardware (equipment) with software (operational solutions), and what we can do to minimize the burden on the field. This requires both knowledge of GMP and a perspective as an operator. Currently, I am working on the establishment of operational procedures of a data collection system to ensure a sterile environment while receiving advice from my seniors.

• Q2When do you find work interesting or difficult?

  When I am elucidating the entire view of aseptic control

  Sterile products, by definition of the term, contain "0" bacteria. However, because bacteria are not visible to the naked eye and can be found anywhere, it is not easy to accomplish this task every day. At the Takaoka Plant, we produce tens of thousands of sterile products every day. In order to continue to ensure that no bacteria exist even when any one of these products is used, many people have accumulated know-how over a long period of time.
  
  Antibodies and cells, which are the core products currently being developed, cannot be sterilized by methods such as heating because if stress is applied, the protein will degenerate, and the medicinal effect will be lost. Thus, in order to ensure the sterility of the products, strict sterility control is applied throughout the manufacturing process. In other words, each process is thoroughly controlled, from environmental control at manufacturing sites to the cleanliness level of the instruments and piping that directly come into contact with the drug solution before filtration (process control). In addition, we periodically verify that the performance of each facility is appropriate (validation). Since there are no means to verify from the outside whether the finished product is sterile or not, we have no choice but to ensure that the entire process is aseptically controlled in this way without any gaps.
  
  This know-how was obtained through a combination of various disciplines, technologies, and ingenuity, rather than something established through university lectures. When I joined the company, I felt that these things were intricately intertwined strings, but when I gradually untied the strings and gained essential knowledge, and when I was able to systematize and understand them, I began to see what was fascinating about aseptic control.

• Q3In your work, what challenges would you like to take on in the future?

  I want to take part in the launch of a new plant as an aseptic control engineer that can meet global standards.

  At present, the core products under development are biopharmaceuticals including antibodies and cells, and we need a factory equipped with aseptic control technology to deliver these products to the world. When starting new plants, we do not simply copy the structure of the Takaoka Plant; we are required to build a better one in light of issues specific to the products being manufactured and the latest regulatory trends. In order to be able to carry out these tasks, we must not just perform our daily tasks, but we must also always be thinking about and considering the rationale for setting process control values, compliance with guidelines, as well as the reason and necessity for conducting the tasks. Although I am still studying now, I hope to be able to play an active and lead role as an expert in aseptic control in any location.
  
  Also, if you can speak English, you will be able to play an active role in the future by transferring technology to overseas sites, responding to inspections, and catching up on the latest regulatory requirements. Fortunately, the Takaoka Plant is actively implementing initiatives with an awareness of globalization. Every day during lunch break, volunteers participate in English discussions, hold monthly information exchange meetings with overseas plants, and there is an English newspaper placed in the cafeteria. In these ways, we are creating an environment where people can enjoy English every day. By making the best use of such an environment, I aim to be able to produce high results in my work while manipulating English as if it were Japanese.
  
  With the rapid increase in the development of biopharmaceuticals, I feel that the need for aseptic control engineers in the company is very high and, even for challenges that may be slightly out of reach, my seniors and supervisors are pushing me forward.

• Q4What is the appeal of working at Astellas?

  I can contribute to providing patients with exciting and attractive new pharmaceutical products.

  Astellas is a leading manufacturer of new pharmaceutical products in Japan. One of our greatest strengths is our continuous focus on new pharmaceutical products. One of the things that surprised me when I joined the company was how many people were involved in the process of making a single pharmaceutical product. Excellent researchers from various fields, such as researchers in the Pharmaceutical Research and Technology Labs, engineers who until recently were here participating in the training, and those I met in the formulation forum and analysis forum during my first year, etc., combine their wisdom to create a new pharmaceutical product. That alone is not an easy task. However, these products cannot be delivered to patients without aseptic control technology. My job is to go through this exactly, and I can always feel that the pharmaceutical products we make may change the future for patients.
  
  I am in charge of investigational products, and new attractive drugs that I myself would be excited about are coming one after another. There are patients waiting for these. We can contribute to that, and that is the attraction of working at Astellas.

A day in the life of Megumi Tamura

* Affiliation at the time of posting.

Employee Q&A

I am responsible for process development for manufacturing investigational drug substances and for improving efficiency and troubleshooting issues in drug substance manufacturing, and am working to ensure stable supply and to maximize the value of drug substances.

Synthetic Drug Substance Manufacturing, Masters in Drug Discovery Science,
joined the company in 2014

Taiga Ota

• Q1What is your current job description?

  I am involved in the development and improvement of manufacturing processes and the validation of efficacy for investigational drug substances, as well as stable drug substance supply.

  The Takahagi Technology Center is a core facility for drug substance manufacturing functions focusing on chemical synthesis, and plays a key role in realizing the stable supply of chemically-synthesized drug substances. Within this environment, Production Technology 1 where I work collaborates with the Pharmaceutical Science & Technology Labs, Chemical & Biological Technology Labs.(CBTL) and others in the development of manufacturing processes for investigational drug substances and the verification of the effectiveness of these processes using pilot plants, and in the supply of manufactured investigational drug substances for toxicologic evaluation and clinical studies in order to realize just-in-time and continuous delivery of new drugs to those who need them.
  In recent years, as drug development has accelerated, there have been more opportunities for our engineers to work closely with laboratories in developing processes that can realize greater efficiency. However, in the manufacture of developmental-stage investigational drug substances, information on physicochemical and bioactive properties is often unavailable, so it is not uncommon for previously unobserved phenomena to occur for the first time during manufacturing. To prevent these kinds of unforeseen issues, it is essential to obtain various data in advance from myriad perspectives during process development, including verification tailored to the equipment being used based on chemical engineering and equipment engineering methodologies, and verification based on operability considerations. Furthermore, by providing feedback of this information, including knowledge gained during manufacturing, to each laboratory and person in charge of manufacturing, we can contribute to the development of efficient manufacturing processes. As a result, environmental considerations, safety measures, quality maintenance, and cost reductions in all manufacturing operations are realized, all of which lead to an early and stable supply of the drug to patients who are waiting for it.
  That is why I feel that the work of Manufacturing Section 1 is very rewarding, and allows me to contribute to the creation of significant value by leveraging various knowledge and technologies.

• Q2When do you find work interesting or difficult?

  I find it fascinating to perform validation in order to solve problems, and to work towards improving quality and operating efficiency.

  In the manufacture of investigational drug substances in particular, scalable outcomes are scarce and data is often insufficient so it is important to identify potentially challenging operations through preliminary validation, and to adopt effective countermeasures. I feel a major sense of achievement when these initiatives for mitigation contribute to process stability and efficiency. The fact that things do not always go as expected is a challenge, but I find this job interesting in that we are constantly working towards solutions through trial and error. The manufacturing of investigational drug substances also involves not only my own department but many other related departments, including the research centers and laboratories. I think the appeal of this job is that a wide variety of people from different backgrounds share their experience, knowledge and skills, and work together to solve common problems.

• Q3In your work, what challenges would you like to take on in the future?

  I would like to further develop my capabilities related to the manufacture of drug substances based on chemical synthesis.

  As I mentioned in my response to the Q1, the relationship between each laboratory and manufacturing site has become closer in recent years. This closer collaboration has made it more important for those of us involved in production to adopt a research perspective as well as a manufacturing perspective. By considering and recognizing the implications of operations involved in manufacturing processes, we can devise and develop more effective methods. I believe that the best human resources are those capable of contributing to the creation of manufacturing processes not from a single perspective, but rather from various perspectives including the environment, safety, quality, delivery, and cost, without having to compromise on what’s important. It is also crucial to access new technologies to strengthen our drug substance production capabilities. In addition to the manufacturing of small molecule drug substance, I would like to expand my potential by learning more about technologies in chemical synthesis and other fields.

• Q4What is the appeal of working at Astellas?

  The appeal of working at Astellas is that it provides an environment where I can proactively pursue new challenges.

  Although the pharmaceutical industry environment and the needs of the public change on a daily basis, Astellas' mission to constantly deliver valuable products to patients remains unchanged.
  Astellas has recently been expanding its efforts not only in pharmaceuticals but also in non-pharmaceuticals (Rx+) with the aim of contributing to patients' physical and mental health. As a company, we are therefore flexibly geared towards the challenge of developing new areas, and as an individual employee, we are given a range of options on how to tackle this challenge. I think the appeal of Astellas is being in an environment where I can think about what I need to do and then pursue challenges in various fields that both leverage my abilities and hone my potential.

A day in the life of OTA

* Affiliation at the time of posting.

Employee Q&A

Master of Bioresource Sciences
Joined the company in 2018

Yoshie Maeda

• Q1What is your current job description?

  To contribute to the stable supply of safe and reliable products by expeditiously and reliably conducting studies and ensuring quality based on accurate data.

  Yaizu Technology Center’s Quality Control Department has a section dedicated to quality testing of commercial and investigational drug raw materials (i.e., drug substances, excipients, and packaging materials), microorganisms, and formulations.
  I am mainly in charge of drug substance testing using high-performance liquid chromatographs, gas chromatographs, infrared spectrophotometers, and other analytical instruments to qualitatively and quantitatively assess their active ingredients and check for impurities, and to ensure they conform to drug manufacturing specifications using accurate data. I contribute to the stable supply of high-quality pharmaceutical products by completing tests accurately and quickly so as not to affect the manufacturing schedule.
  I am also part of an interdepartmental Foreign Matter Analysis Team. Our analyses cover all pharmaceutical products, investigational drugs, raw materials, and formulations. They include foreign substances found in raw materials or generated in manufacturing processes, and those related to product complaints from healthcare providers, such as analyzing broken tablets. Contamination by foreign matter is strictly prohibited in pharmaceuticals on which patients’ lives depend. To ensure the continued delivery of safe and reliable pharmaceuticals to patients, we strive to reduce the risk of contamination by expeditiously performing analyses, identifying the cause of contamination, and working with the Manufacturing Department and other relevant departments. The work of the Foreign Matter Analysis Team also allows me to learn about topics other than raw materials so it has helped broaden my knowledge and perspectives, which in turn gives me a feeling of personal development every day.
  Since starting this job, I have realized the importance of such awareness.
  Even if our test results fall within the reference range, it is essential to notice anything unusual and to explore the potential causes of anomalies from various perspectives. When analyzing foreign matter, it is crucial to notice and estimate potential sources of foreign matter risks based on identified elements. We are constantly noticing and investigating these risks on a daily basis, and we implement the necessary improvements to achieve even higher levels of quality control.
  All of our work involves a great deal of responsibility. We strive to realize ever-higher levels of quality control, and engage in our work with a genuine sense of urgency and responsibility. I feel that my work contributes to Astellas' drug manufacturing, which is very rewarding in itself.

• Q2When do you find work interesting or difficult?

  When I’m challenging myself to learn analytical techniques for new drug substances.

  At the Yaizu Technology Center, new products have been launched every year since I joined the company, and I have been involved in the quality testing of several new drug substances. To perform quality testing of new drug substances at the Yaizu Technology Center, analytical technology transfers are needed to acquire the necessary analytical technology from laboratories with relevant expertise or from drug substance manufacturing sites outside Japan. Many things don’t go smoothly or are uncertain when we study a new test method for the first time. We overcome these issues and uncertainties by consulting with our experienced senior staff and by working closely with laboratory personnel to gather the information needed to facilitate future testing. The process of solving problems one by one is interesting despite the inherent difficulties because it allows me to expand my knowledge of testing methods and analytical equipment. What’s more, solving problems in an ad hoc manner is certainly not ideal for ensuring the stable operation of quality testing in compliance with GMP. It is crucial to implement systems that guarantee a consistent testing environment in which all analysts can perform tests with the same degree of precision and without error, regardless of when or under what circumstances the test is performed. I feel challenged on a daily basis, not only in terms of my skills and knowledge of testing methods and equipment, but also because I need to a flash of idea as an analyst and to be flexible in my ideas; however, I find it interesting.

• Q3what challenges would you like to take on in the future?

  I would like to try analyzing new fields such as antibody drugs and biopharmaceuticals.

  To date, the Yaizu Technology Center has been manufacturing pharmaceuticals, primarily solid preparations (small molecule drugs), but we are now planning to start manufacturing antibody drugs. I was fortunately involved in the transfer of analytical technologies for antibody drugs. Because antibody drugs have entirely different properties and characteristics from those of small molecule drugs, we have to perform tests using new equipment that we have never handled before and there are many things that we cannot understand using our existing expertise and technologies in the analysis of small molecule drugs. I hope to learn more about antibody drugs, various analytical techniques, and equipment so as to minimize the potential unknowns that we may encounter. I would also like to further my knowledge of various national regulations and contribute to developing GMP-compliant systems that will ensure higher quality control levels. In the future, I intend to challenge myself to become a more capable analyst not only of small molecules and antibody drugs, but also new biopharmaceuticals, with the aim of developing the analytical skills and knowledge required to handle a wide range of drugs.

• Q4What is the appeal of working at Astellas?

  I feel the most attractive point is that I can continue to contribute to patients around the world who are waiting for medicines.

  Astellas is a company that continues to pursue challenges in the development of new drugs. We are focused not only on our specialist fields but also on research and development of advanced and cutting-edge drugs targeting viruses and cells. This approach allows me to feel involved in the future development of various new drugs even while working in manufacturing, which is the most appealing aspect of the job.
  Although it doesn’t directly result in the creation of new drugs, quality control work is vital for ensuring that the highest quality drugs are delivered to patients as expeditiously as possible. This is a rewarding job where I can play a part in constantly delivering safe and reliable medicines to patients around the world through drug quality assurance based on accurate data.
  Astellas also has many departments covering research, medical & development, pharmaceutical technology, engineering, manufacturing, and marketing. These different departments handle everything from drug research and development to manufacturing and sales. I believe that the appeal of Astellas is that the various departments within the company allow us to closely collaborate efficiently to ensure the stable supply of medicines. The Yaizu Technology Center where I work comprises not only the plant but also the Formulation Research Center and Materials Research Center on the same site, and this layout facilitates interdepartmental communication. By sharing opinions from various perspectives and working closely together, we are able to manufacture investigational drugs, launch new products quickly, and ensure a stable supply of existing products.

A day in the life of Yoshie Maeda

* Affiliation at the time of posting.