Roundtable Discussion: Rethinking mRNA Drug Substance Outsourcing: Designing Quality, Control & Scalability into External Manufacturing

• 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

Speakers:

Antonio Grilo

Associate Director External Manufacturing

MSD