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Merck Workshop: mRNA Regulatory and production technology

September 6, 2022

6 September
mRNA Regulatory and Production technology

 

Watch on-demand: click 

 

Topic 1: Key quality considerations on mRNA within an Integrated mRNA CDMO offering

By: Dr. Julian Mochayedi

Strategic Marketing Manager for mRNA solutions

Life Science Services, Synthesis & ADC CDMO (SAC)

 

Abstract: mRNA-therapeutics have become the most discussed and growing modality in recent years. While COVID vaccine development occurred in record time, critical design and quality attributes must be considered when developing mRNA applications. This presentation covers the key quality attributes impacting mRNA performance to ensure success. Furthermore, we discuss how our unique PCR-based mRNA CDMO Service technology can accelerate mRNA development & manufacturing and the benefits of an integrated CDMO offering including Lipids, LNP formulation and final fill & finish.

 

Topic 2: Regulatory Points to be considered for mRNA vaccine

By: Mr. Jeong-Hoon Lee
Regulatory Management Specialist 

Abstract: In this session, regulatory aspects of mRNA vaccine manufacturing (along with manufacturing process overview) and IND, NDA preparation will be presented by leveraging guidance in S. Korea. In addition, US FDA, EMA regulation and industrial guidance for mRNA vaccine will be introduced.

Topic 3: mRNA Facility Qualifications & Key Watchouts

By: Mr. Larry Zhu
Senior Quality & Validation Consultant

China Pharma Regulatory Advocacy & Consultancy Service

Abstract: Qualification of critical facility is required by regulation. In the presentation, validation lifecycle of facility qualification will be shared, each phase of validation lifecycle will be introduced detail to meet China, EU, FDA requirements.

 

 

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