ENGLISH - CASSS Introductory Comments, CMC Strategy Forum Japan Welcome and Recent Trends in the Regulation of Biopharmaceutical Products

Dec 6, 2021 9:00am ‐ Dec 6, 2021 1:30pm

JAPANESE - CASSS Introductory Comments, CMC Strategy Forum Japan Welcome and Recent Trends in the Regulation of Biopharmaceutical Products

Dec 6, 2021 9:00am ‐ Dec 6, 2021 1:30pm

ENGLISH - Continuous Manufacturing of Biologics

Dec 7, 2021 9:00am ‐ Dec 7, 2021 12:10pm

Continuous Manufacturing (CM) of biologics has been a hot topic for recent years because it has a potential for improving the efficiency, agility, and flexibility of drug substance and drug product manufacturing. In addition, ICH Q13 reached to step 2 on July 27, and is expected to progress to step 4 next year. This session will discuss ICH Q13 updates and perspectives from regulators and industry for CM of biologics.


JAPANESE - Continuous Manufacturing of Biologics

Dec 7, 2021 9:00am ‐ Dec 7, 2021 12:10pm

Continuous Manufacturing (CM) of biologics has been a hot topic for recent years because it has a potential for improving the efficiency, agility, and flexibility of drug substance and drug product manufacturing. In addition, ICH Q13 reached to step 2 on July 27, and is expected to progress to step 4 next year. This session will discuss ICH Q13 updates and perspectives from regulators and industry for CM of biologics.


ENGLISH - Challenges of Vaccine and Biotherapeutic Therapies for COVID-19

Dec 8, 2021 9:00am ‐ Dec 8, 2021 12:40pm

In this session, the strategies/approaches to address the challenges of accelerated CMC development for new modalities will be discussed, based on recent experiences with fast-to–market of vaccines and therapeutics for COVID-19. The accelerated CMC development for global supply to billions of patients should bring challenges for global submission, lifecycle management and post-approval changes. Considering should be given to scale-up manufacturing, demonstrating comparability of process and product with limited batch history, site-transfer, process validation, and so on. The unique challenge of agreeing clinically relevant global specifications that have significant impact on maximum shelf life and storage conditions, ability to manage variability in manufacture and consequently supply and distribution to patients. Limited platform data or prior knowledge, in the case of new modality, could increase challenges. As this Session covers topics relating approaches to overcome these challenges including:

1. Challenges in CMC rapid review/approval for stability studies from J-HA.
2. Challenges in CMC rapid review/approval for manufacturing method, specification and test methods and stability studies from industry.
3. Point to consider for developing new modality derived from mRNA.
4. Issues and ingenuity in expanding the production lines.
5. Challenges in analytical tech transfer to NIID for new modalities.
6. Ingenuity in ultra-low temperature transportation (Ad-hoc).


JAPANESE - Challenges of Vaccine and Biotherapeutic Therapies for COVID-19

Dec 8, 2021 9:00am ‐ Dec 8, 2021 12:40pm

In this session, the strategies/approaches to address the challenges of accelerated CMC development for new modalities will be discussed, based on recent experiences with fast-to–market of vaccines and therapeutics for COVID-19. The accelerated CMC development for global supply to billions of patients should bring challenges for global submission, lifecycle management and post-approval changes. Considering should be given to scale-up manufacturing, demonstrating comparability of process and product with limited batch history, site-transfer, process validation, and so on. The unique challenge of agreeing clinically relevant global specifications that have significant impact on maximum shelf life and storage conditions, ability to manage variability in manufacture and consequently supply and distribution to patients. Limited platform data or prior knowledge, in the case of new modality, could increase challenges. As this Session covers topics relating approaches to overcome these challenges including:

1. Challenges in CMC rapid review/approval for stability studies from J-HA.
2. Challenges in CMC rapid review/approval for manufacturing method, specification and test methods and stability studies from industry.
3. Point to consider for developing new modality derived from mRNA.
4. Issues and ingenuity in expanding the production lines.
5. Challenges in analytical tech transfer to NIID for new modalities.
6. Ingenuity in ultra-low temperature transportation (Ad-hoc).