mRNA Regulatory and Production technology
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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.