Biopharma Group’s state-of-the-art GMP (Good Manufacturing Practice) freeze drying production facility supports partners with the transition of their product from the research and development phase into clinical manufacture. The UK based GMP facility has been designed to accommodate small batch manufacture of both cyto and non-cytotoxic products for first-in-human (FIH) trials. Biopharma Group offers access to fast and efficient GMP manufacturing slots paired with flexible manufacturing solutions to enable the delivery of projects on time and within budget.
Biopharma Group’s team understands the challenges around transitioning products from R&D into GMP manufacture. With a world leading reputation for research and development, our skilled scientists are on hand to support with process optimization requirements and tech transfer both in, and out of our UK facility.
The fundamentals of GMP manufacture include:
- People: Our production scientists are competent and trained in cGMP and “Right First-Time” manufacturing techniques and principles.
- Products: Our detailed on-boarding process ensures all product specifications are documented and approved from material procurement to in-process and final testing.
- Processes: Biopharma Group offers R&D, feasibility and engineering batches prior to GMP production to ensure processes are fully tested and validated.
- Procedures: Biopharma Group has developed detailed SOP’s, BMR’s and EOP’s to ensure both the consistent manufacture of product and full batch traceability.
- Premises: The GMP facility has been validated and maintained to the required regulations. Biopharma Group welcomes our partners to audit our facility prior to any collaborations.
Download a copy of our Pharmaceutical Services & Solutions overview brochure.
