Case Study Overview
For clinical-stage biotechs moving toward Phase III, defining a manufacturing strategy and building effective CDMO Quality Oversight are critical. Without structured governance, outsourced operations can cause delays, compliance gaps, and investor concerns. This case study shows how GMP Bridge supported a biotech with facilities in North America and Europe by delivering a risk-based manufacturing strategy and implementing a robust Quality Oversight framework.
The Challenge
A fast-growing clinical biotech preparing for Phase III needed to define its manufacturing approach while scaling operations. With multiple CDMOs, no formal oversight model, and increasing delays in batch release, the company required strategic guidance and hands-on implementation to regain control over outsourced manufacturing.
