Client: Multinational Biotech Company
Duration: 10 months
Project Role: Project Lead - GMP Bridge Senior Partner
Location: Germany
Project Overview:
GMP Bridge was engaged by a multinational biotech company to lead a one-year CMC project focused on the development and delivery of biologic drug products. Our Senior Partner took on the role of Project Lead, utilizing their expertise to ensure that all processes and deliverables were executed efficiently and met the highest standards.
Key Deliverables:
- Analytical Testing & Stability Studies: We executed critical analytical tests and stability studies, ensuring product integrity and compliance with regulatory standards.
- Comprehensive Data Documentation: All experimental data, including test results, evaluations, and reports, were meticulously documented and interpreted, ensuring clear communication with the project’s stakeholders.
- Team Leadership & Collaboration: As Project Lead, the Senior Partner managed the Drug Product (DP) development sub-team, ensuring cohesive collaboration with the CMC team and driving project success.
- Method Development & Technological Innovation: Our team contributed to the development of new laboratory methods and the adoption of innovative technologies, further enhancing the project’s outcomes.
Results:
- On-Time Delivery: The project was delivered on schedule, allowing the client to progress with regulatory submissions for their biologic products.
- Enhanced Product Quality: GMP Bridge's leadership ensured high-quality results, reinforcing the client’s biologic product pipeline with validated data and optimized processes.