Client Profile
- Country: Switzerland
- Type of Company: Clinical-stage biotech preparing for Phase III
- Products: Recombinant proteins and sterile drug product (vials)
Challenge
The client, a fast-growing clinical-stage biotech, needed to define its manufacturing approach while scaling up operations. Core challenges included:
- No clear make-or-buy strategy for drug substance and fill & finish
- Multiple CDMOs involved without structured Quality Oversight
- Increasing issues with batch release delays, deviations, and data availability
- Lack of formal governance over CDMO activities and documentation
- Insufficient control over aseptic manufacturing processes outsourced to partners
Solution Delivered
GMP Bridge supported the client with a dual approach:
- Manufacturing Strategy Advisory:
- Structured analysis of in-house vs. outsourced production options
- Evaluation of CDMO partners from a Quality & compliance perspective
- Definition of optimal manufacturing setup for late-phase development
- CDMO Quality Oversight Program Design:
- Establishment of formal Quality Oversight processes and governance model
- Development of oversight routines covering batch release, deviations, and change control
- Implementation of KPIs to monitor CDMO performance and drive accountability
- Training of internal QA staff on managing outsourced aseptic manufacturing
- Creation of practical tools for documentation control and deviation follow-up
Impact & Results
- Clear, risk-based manufacturing strategy aligned with clinical and commercial goals
- Reduced batch release delays and improved issue resolution with CDMOs
- Robust Quality Oversight Program implemented, ensuring better control over external manufacturing
- Enhanced collaboration with CDMOs while retaining process ownership internally
- Improved investor and regulatory confidence in supply chain robustness
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