In recent years, RNA-based therapeutics, particularly siRNA and mRNA-based drugs, have revolutionized the field of medicine. In this webinar, we will delve into the categorization of mRNA-based therapeutics in the European Union and the United States and examine the manufacturing requirements for mRNA drug substances in each region. Gain insights into the benefits of these regional differences for mRNA drug product development. Stay informed on the latest EU and US regulations impacting mRNA therapeutics, from drug substance to lipid nanoparticle (LNP) formulations. Stay ahead of the evolving regulatory landscape and discover opportunities for your mRNA drug development strategies.
In this webinar, you will:
- Understand the distinct regulatory categorizations of mRNA therapeutics in the European Union and United States
- Learn about the advantages of an EU-based mRNA drug substance manufacturer
- Gain insights into regulatory requirements for LNPs in mRNA-LNP formulation
Speakers
Oliver Daniel Schwich, Ph.D.
MilliporeSigma
Regulatory Expert - LSS Regulatory Management
Oliver is a regulatory expert for mRNA drug substance offering located at the mRNA Center of Excellence in Hamburg, Germany. He is responsible for surveillance of mRNA-related guidance, assuring their phase appropriate application and supporting customers regarding drug substance CMC sections.
Before joining MilliporeSigma, Oliver worked as as RA Manager for a Swiss generic pharmaceutical company. He holds a master’s degree in biotechnology from the Technical University Braunschweig, Germany, and a Ph.D. in cellular RNA biology from the University Frankfurt, Germany.
Melike Uzun
MilliporeSigma
Regulatory Expert - LS Regulatory Management
Mel is a regulatory expert within pharma registration at MilliporeSigma. Her responsibilities include CMC - particularly Module 3 Quality for established APIs, excipients, as well as manufacturing authority and GMP-certificate activities for mRNA-based drug substances with the respective competent authority.
Prior to joining MilliporeSigma, Mel gained relevant mRNA-based therapeutic, and vaccine application experience from industry including BioNTech, Mainz Germany, and Moderna, Cambridge, MA, USA. Mel holds a BS in biotechnology from the University of Maryland, USA, and an MDRA from the University of Bonn, Germany.
Pharma and biopharma manufacturing
- mRNA
Duration:51min
Language:English
Session 1:presented May 14, 2024
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