Antonio Grilo
Associate Director External Manufacturing MSD
Seminars
Wednesday 20th May 2026
Roundtable Discussion: Rethinking mRNA Drug Substance Outsourcing: Designing Quality, Control & Scalability into External Manufacturing
9:45 am
- Positioning outsourcing as a strategic quality and control decision, assessing how choices around pDNA, enzymes, lipids and consumables directly influence mRNA drug substance robustness, impurity burden and downstream manufacturability
- Defining fit-for-purpose outsourcing strategies across development stages, evaluating how expectations of CDMOs and external partners must evolve from early research through GMP scale-up and commercial readiness
- Critically assessing external manufacturing partners beyond capacity, including process understanding, analytical transparency, comparability support and readiness for increasing regulatory scrutiny
