Pharmaceutical Manufacturing
Continuous manufacturing, QbD, biosimilars, supply-chain.
Pharmaceutical manufacturing is under unprecedented scrutiny following nitrosamine recalls, the GLP-1 shortage and compounding controversy, and the geopolitical re-shoring push under the CHIPS-and-Science-era industrial policy. WCPD 2027 will cover continuous manufacturing adoption (Janssen, Vertex, Eli Lilly), Quality-by-Design implementation under ICH Q12, and PAT-driven release. Sessions will also address mRNA and LNP manufacturing scale-up post-pandemic, viral vector capacity constraints, generics quality and the FDA's GDUFA III commitments, drug shortage prevention under the CARES Act reporting requirements, and the emerging role of distributed and point-of-care manufacturing for personalized cell therapies.
- Continuous manufacturing and ICH Q13 implementation
- mRNA, LNP, and viral vector manufacturing scale-up
- Nitrosamine impurity control and root-cause investigation
- GLP-1 supply chain, compounding, and FDA shortage list
- Generics quality: GDUFA III, FDA foreign inspections
- Distributed and point-of-care cell therapy manufacturing
- PAT, real-time release, and Quality-by-Design (ICH Q8-Q12)