CPHI Americas
Symbiosis Completes MHRA Audit of New Sterile Fill/Finish Facility
Newly expanded GMP facility enhances aseptic fill/finish, handling of cytotoxic and high-potency compounds, and scalable batch sizes.
Symbiosis Pharmaceutical Services, a global sterile fill/finish contract manufacturing organization (CMO), has successfully passed its recent audit conducted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This follows an inspection of its newly constructed Bruce Building, a 20,000 sq ft aseptic facility that contains an automated fill/finish line for the sterile production of injectable drug products, including both small molecules and biologics.
This successful audit marks another step in Symbiosis’ £26 million strategic investment to scale its commercial manufacturing capabilities.
The new expanded GMP facility enhances Symbiosis’ services for:
- Aseptic fill/finish of liquid parenteral drug products
- Handling of cytotoxic and high-potency compounds
- Scalable batch sizes from preclinical to commercial
“This extension of our current MHRA licenses reflects the strength of our team and the robustness of our quality systems. For our clients, this solidifies confidence in our ability to accelerate the delivery of their sterile drug products to patients worldwide within a tightly regulated landscape,” said Colin MacKay, CEO of Symbiosis.
