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).