Buffer Solutions

The global biopharmaceutical market is growing substantially at an increasingly fast pace. In-house manufacturing facilities are increasingly at capacity.

• 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.

• 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-Bag^TM) to customer specification.
• Full documentation and release testing on all materials. Testing requirements specified by the customer.
• Customised single use Bio-Bags^TM 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).