cGMP Manufacturing Services

Successful manufacturing depends on experienced people, strong processes, and a smooth transition from one stage to the next. At Gannet BioChem, the teams who help refine your early-phase process are the same teams who guide it into cGMP production, creating continuity that reduces risk and shortens timelines.

With decades of polymer science and cGMP manufacturing experience, we support programs at any stage and scale production as your therapeutic advances, ensuring consistent quality and dependable delivery throughout the life cycle.

Our early-phase manufacturing capabilities are built for flexibility, rapid iteration, and close collaboration. Whether you’re preparing materials for preclinical studies or refining your process before entering cGMP production, our team works closely with you to optimize conditions and lay the foundation for future scale-up.

Capabilities include:

• Reactor capacities up to 200L for agile batch production
• Custom synthesis tailored to molecule-specific requirements
• Integrated analytical methods supporting purity, identity, and impurity control
• Long-standing supplier relationships ensuring reliable raw material sourcing

These capabilities support test batches for in vivo studies, preclinical cGMP materials, and initial cGMP reagent production for CDMOs or in-house manufacturing teams. Our development and analytical method development teams remain closely involved to ensure your process is ready for larger-scale execution.

As your program enters later clinical phases or commercial readiness, Gannet BioChem provides the expertise and infrastructure needed to scale efficiently and consistently. Our history supplying nine FDA-approved therapies reflects our ability to meet demanding volume, purity, and reliability requirements.

Capabilities include:

• Reactor capacities up to 800L for high-volume production
• Infrastructure designed to support seamless clinical-to-commercial transitions
• Established sourcing strategies for consistent raw material quality
• Manufacturing workflows optimized for efficiency, reproducibility, and dependable delivery

Our team supports both new programs scaling up within our facility and established processes transferring in from external partners.

Quality is embedded in every aspect of our cGMP manufacturing operations. Our site has a long-standing track record of successful FDA and client audits, and our internal quality system is built to ensure transparency, precision, and compliance at all scales.

Analytical testing is performed in-house, allowing rapid turnaround, aligned communication between manufacturing and analytical teams, and timely release of materials. Documentation, batch records, and regulatory support are structured to meet the expectations of both clinical and commercial programs.

Manufacturing at Gannet BioChem is a hands-on, collaborative experience. We maintain open communication with partners throughout development and production, providing clear visibility into process status and decisions. Clients are welcome on-site for laboratory work, pilot demonstrations, and initial manufacturing runs, ensuring full alignment as programs progress toward scale.