The global biopharmaceutical market is growing substantially at an increasingly fast pace. In-house manufacturing facilities are increasingly at capacity.
Benefits of outsourcing:
- Larger finished-drug manufacturing capacity.
- Lower in-house bioprocess and capital costs, outsourcing preparation responsibilities (including handling QA/QC and regulatory documentation), eliminating the need for buffer-dedicated manufacturing space or preparation staff.
- Local off-site safety stock held for immediate call-off.
What can be achieved:
- Outsourced materials made with Water for Injection (WFI).
- Manufactured in a GMP compliant facility.
- Customer-driven stability studies conducted by manufacturer.
- Use of multi-compendial starting materials.
- Novel sampling (from Bio-BagTM) to customer specification.
- Full documentation and release testing on all materials. Testing requirements specified by the customer.
- Customised single use Bio-BagsTM with customised connections and tubing to fit vessel connections. Customised packaging allowing direct release into high risk areas, easing the incoming burden for the client.
- Client specific packaging easily facilitated.
- Safety stocks held.
- Time spent on-site to fully understand the needs of the client.
Our partnership with A&C allows us to custom manufacture buffer solutions. The Buffers are produced in a GMP facility in Ireland (EU).