09.22.26 -- FDA Not A Good FRAME for CDMO Inspections?

See how collaboration-driven raw material control reduces variability, improves cell culture performance, and delivers measurable cost and productivity gains in biotherapeutic manufacturing.

Early research choices shape outcomes. Focusing on reproducibility, scalability, regulatory fit, and supply stability early cuts risk, prevents delays, and supports smoother development progress.

Build bioprocessing resiliency with strategic supply chain management. Learn to meet quality, compliance, and time-to-market demands amid global volatility with effective sourcing.

This panel session features a decade-long story of partnership in bringing two life-changing gene therapies to market successfully.

Reliable hcDNA monitoring can improve bioprocess performance, support compliance, and guide upstream and downstream decisions that impact quality and yield.

Discover how the evolution of T7 polymerase is optimizing in vitro transcription for RNA therapeutics. Learn to balance performance, cost, and supply to make smart choices for your xRNA manufacturing.

mRNA developers face a regulatory gap: as of 2024, neither FDA nor EMA has issued CMC-specific guidelines. Learn how early regulator engagement and CDMO partnerships reduce risk.

Fragmented manufacturing increases tech transfer risk, delays timelines, and causes data loss. A unified framework preserves continuity and accelerates advanced therapy delivery.

Transitioning from fresh to frozen starting material stabilizes cell therapy inputs, but isolated workflows introduce risk. Integrated logistics safeguard quality as trial footprints expand.