Abhi Kavathia
Associate Director GMP/CMC Drug Product BioNTech
A strategic CMC leader with over 13 years of experience in drug product development across mRNA-LNP vaccines, complex injectables and biologics. Currently Associate Director, GMP/CMC Drug Product Lead at BioNTech, he leads CMC strategy for innovative vaccine programmes, spanning formulation and process development, QbD implementation, technology transfer and regulatory readiness across clinical development. He has developed and optimised more than 20 drug products and supported 15+ global technology transfers and multiple IND/IMPD submissions. He is also a member of the USP Expert Committee for General Chapter Dosage Forms (USP cycle 2025–2030).
Seminars
Thursday 18th February 2027
Panel Discussion: Navigating Evolving Regulatory Expectations as mRNA Moves Beyond Vaccines
4:30 pm
- Clarifying EMA & MHRA expectations for mRNA drug substance, drug product, biodistribution, toxicology & immunogenicity as therapeutic applications diversify
- Understanding how regulatory requirements differ across vaccines, protein replacement, oncology, gene editing & other emerging mRNA applications
- Addressing the regulatory classification of mRNA products, including where non-genome-altering mRNA and mRNAenabled gene editing fit within existing frameworks
- Keeping pace with evolving global guidance while identifying where RNA-specific regulatory expectations remain unclear
Friday 19th February 2027
Adapting CMC & Quality by Design for Individualised mRNA-LNP Therapies
11:30 am
- Applying phase-appropriate CMC strategies to enable the efficient development and clinical translation of individualised mRNA-LNP therapies
- Leveraging Quality by Design (QbD) principles to build product and process understanding while maintaining flexibility for patient-specific treatments
- Addressing comparability, control strategy, and regulatory considerations in the evolving landscape of personalised medicines
