Client Profile
- Country: United States (Investor) / Europe (Target Company)
- Type of Company: US-based biotech investor evaluating acquisition target
- Target Company: European sterile drug substance manufacturer
- Products: Recombinant proteins and sterile intermediates
Challenge
A US biotech investor was evaluating the acquisition of a European manufacturer specialized in sterile biologics. They required an independent, expert assessment of:
- GMP compliance and regulatory history of the target company
- Quality systems maturity and scalability for future growth
- Supply chain robustness and key operational risks
- Potential remediation needs and hidden liabilities
- Management’s technical competence and operational culture
The investor needed clear, actionable insights to support their acquisition decision.
Solution Delivered
GMP Bridge was selected as technical advisor to perform a full GMP and operational due diligence audit, including:
- Comprehensive onsite assessment covering Quality Systems, manufacturing operations, and supply chain
- Evaluation of inspection history, deviation/CAPA management, and contamination control practices
- Assessment of batch release performance, Quality Oversight, and sterility assurance framework
- Identification of potential remediation costs, operational risks, and regulatory vulnerabilities
- Interviews with key site leadership to assess management competence and mindset
- Detailed due diligence report, including risk categorization, required investments, and post-acquisition priorities
- Direct collaboration with the investor’s legal and financial teams during the acquisition process
Impact & Results
- Clear risk profile and operational assessment of the target company
- Identification of hidden liabilities and remediation costs impacting acquisition valuation
- Strategic recommendations provided for post-acquisition integration and operational improvements
- Enabled informed investment decision and negotiation based on objective operational data
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