Quality By Design: The Highest-Standard Approach To Process Validation For Early And Late-Stage Projects

The challenge here was to develop and validate manufacturing processes for two novel molecules, one in phase 1 development and the other in phase 3.

AGC Biologics is committed to providing its clients with Quality by Design, an approach to Process Development based on formalized methods and Quality System infrastructure that simultaneously support at-scale manufacturing for early-phase clinical trials and scale-up to meet late-phase clinical and commercial needs.