Andelyn Biosciences Capabilities Update October 2026: Cell & Gene Therapy

From Late-Stage Clinical Programs to Commercial Launch: What True Manufacturing Readiness Requires in Advanced Therapies

An FDA approval or a successful pre-license inspection validates years of scientific development, but regulatory milestones reflect commercial capabilities established long before filing. Transitioning an AAV program to commercial launch requires deep process characterization, robust analytical control, and an embedded quality culture throughout development.

This session examines the operational realities of commercial manufacturing, using recent regulatory decisions as real-world proof points for building a reliable, long-term patient supply.

What You'll Learn:

• How to de-risk Process Performance Qualification (PPQ) to ensure repeatable, batch-to-batch consistency.
• What regulatory authorities prioritize during on-site Pre-License Inspections (PLI), from facility design to contamination control.
• Why analytical assay lock and commercial readiness must be established long before submitting a filing.
• How to align sponsor and CDMO teams through transparent governance and secure critical starting materials to protect launch timelines.