5th mRNA Process Development & CMC Summit

Key questions include:

• How do you structure CDMO partnerships to balance speed, flexibility, and risk without overcomplicating your manufacturing network?
• What are the biggest misalignments between biopharma and CDMOs during scale-up – and how can they be avoided early?
• At what point should companies start designing for commercial-scale manufacturing, and how does that shape CDMO and supply chain decisions?

• How early, structured CDMO engagement can reduce development risk and shorten timelines for mRNA, neoantigen and personalised cancer vaccine programmes in cell & gene therapy pipelines
• Aligning process development and CMC expectations between biopharma and CDMOs to avoid scale-up failures and enable smoother translation from preclinical to commercial supply
• Defining effective partnership models for complex modalities, including tech transfer best practices, capacity planning, and managing variability in patient-specific manufacturing workflows