The Process Development Blog

Small molecules still dominate FDA approvals, but rising stereochemical and solid-state complexity demands stronger CMC strategies for 2026 readiness.

This on-demand webinar from The Medicine Accelerator examines how ATMP developers can move from lab-scale development toward GMP manufacturing with stronger process understanding, quality control, and technology transfer planning. The session focuses on an oncolytic virus case study that achieved a 400% increase in viral yield and a 90% reduction in cost per dose. Topics include ATMP process development, upstream and downstream optimization, impurity profile improvement, manufacturability, GMP readiness, regulatory considerations, tech transfer, clinical manufacturing capacity, and faster time to patient.

A lack of process understanding & control leads to: inability to scale, product quality drift, & costly delays from batch failures & regulatory concerns