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Sakurai Lab
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A lab that supports pharmaceutical quality assurance through research on standards and human resource development.
AboutAbout the lab
Supporting pharmaceutical quality assurance through standards and people.
The Sakurai Lab works on quality assurance of pharmaceuticals and regenerative medicine products from two sides: research on standards and human resource development.
It is a social collaboration chair established at Tokyo University of Science in July 2020, aiming to support stronger collaboration among industry, government, and academia through education and research on the quality and GMP of pharmaceuticals and related products.
The lab's mission is to promote regulatory harmonization through research on global standards and guidelines, and to apply the latest knowledge gained to human resource development.
On the lab's website, it is introduced under the name “Pharmaceutical Quality and GMP Chair.”
Key terms
- GMP
- Good Manufacturing Practice: standards for manufacturing control and quality control that pharmaceutical manufacturing sites must follow
- Regulatory science
- An effort to harmonize regulations through research on global standards and guidelines
- Social collaboration chair
- A chair established to strengthen collaboration among industry, government, and academia. This chair was established in July 2020
ResearchResearch themes
With the question of how to ensure the quality of pharmaceuticals and regenerative medicine products, including those with new modalities, the lab works toward regulatory harmonization (regulatory science) through research on global standards and guidelines. It also aims to apply the latest knowledge gained to human resource development, hoping that this ultimately leads to the safety and peace of mind of patients.
*Illustrative imageE-learning on GMP for the shop floor
To explain GMP to staff at every level of a manufacturing site, the lab develops easy-to-understand educational materials in collaboration with a publisher and distributes them in sequence. They are designed so that learners from beginners to experienced staff can study from both regulatory and technical perspectives.
*Illustrative imageQbD and regulation of regenerative medicine products
As a research activity of the Japan Agency for Medical Research and Development (AMED), the lab is in charge of the Regulation and Systems WG among the groups of working groups centered on Prof. Kino-oka of Osaka University. It studies how the QbD approach for regenerative medicine products should be handled under regulations and investigates the regulatory situation overseas.
*Illustrative imageTraining materials for vaccine manufacturing
As an AMED research activity, under the principal investigator at BCRET (a general incorporated foundation), the lab develops educational materials for people involved in the manufacturing and development of new types of vaccines that use mRNA or viral vectors. Within this project, the Sakurai group turns the key points of industrial production (regulatory requirements, manufacturing control, and quality control) into teaching materials.
*Illustrative imageDeveloping a draft GMP audit manual
This is the activity of the GMP research group within the Ministry of Health, Labour and Welfare Administrative Promotion Research Project “Research on the international harmonization of GMP, QMS, and GCTP guidelines.” The lab is developing a draft audit manual that contributes to the effective operation of pharmaceutical quality systems and to effective audits of manufacturing sites by marketing authorization holders.
MembersFaculty
The members of the Pharmaceutical Quality and GMP Chair consist of a professor, engineers, experts, and a research support administrative assistant.As of 2026
- ProfessorShingo Sakurai
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Report an errorAbout the images
The top and research theme images are illustrative and were not taken at the lab. They are cropped from Wikimedia Commons images. Cropped CC BY-SA images are provided under the same CC BY-SA license as the original (version shown on each line).
- Top image: “Tula Pharmaceutical Factory 04” Пресс-центр Правительства Тульской области. / CC BY 4.0 (cropped)
- E-learning on GMP for the shop floor: “Italy, E-Learning, Covid19” Nessma Elaassar / CC BY-SA 4.0 (cropped)
- QbD and regulation of regenerative medicine products: “Regenerative-Medicine-Stem-Cells-Tissue-Engineering-Biomaterials” Umargani Jamal Mohamed / CC BY-SA 4.0 (cropped)
- Training materials for vaccine manufacturing: “COVIran Barekat vaccine production 10” Sadegh Nikgostar / CC BY 4.0 (cropped)
- Developing a draft GMP audit manual: “Hand tablet press in exposition History of making of drugs in Kuks Hospital in Kuks, Trutnov District” Jiří Sedláček / CC BY-SA 4.0 (cropped)
- Related lab (羽田研究室): “Maou” Hanabishi / CC BY-SA 3.0 (cropped)
- Related lab (高橋研究室): “Inside the Medicinal Chemistry Lab ( )” National Center for Advancing Translational Sciences from Bethesda, MD / Public domain (cropped)
- Related lab (中田研究室): “Captive's medical clinic, Camp 6, Guantanamo” DoD / Public domain (cropped)
- Related lab (佐藤(嗣)研究室): “Antique medicine and chemical bottles in Cedar Key Historical Museum in Cedar Key, Florida, US, on 23 January 2021” MatthewHoobin / CC0 (cropped)
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