BUFFER MANUFACTURING
Buffer fluid may be a costly bottleneck in the downstream processing of biopharmaceuticals. Producing these liquids internally necessitates regulatory supervision, quality control, and specialized space, tools, and personnel for buffer preparation, handling, and manufacture.
For your buffer outsourcing and cleaning solution needs, A&C provides affordable, adaptable, and customized solutions. They also consistently give complete release testing and accompanying documentation.
GMP buffer and ingredient blend portfolio
Our GMP and ISO 9001:2015 certified facilities allow us to create buffers on your behalf. At A&C, we have extensive experience in buffer manufacturing.
In accordance with Good Manufacturing Practices (GMP), we produce buffers, process solutions, cleaning solutions, custom liquid mixes, and Water for Injection (WFI). Where applicable, our buffers and solutions satisfy all current monographs and compendial grades (USP/EP/BP/JP/Multicompendial).
The bulk of the products in our extensive assortment of GMP buffers and ingredient blends are custom blends, solutions, or dilutions. Water for Injection is used in the manufacturing of all of our buffers so they can be processed further. Among the product types are:
- Phosphate buffer solutions
- Caustic solutions
- Salt solutions
- Acid solutions
- Solvent blends
- Acid blends
- Water for Injection (WFI) for further processing
- Buffer concentrates
A&C has experience carrying out technology transfer protocol requirements for customers seeking to outsource proprietary products. Our expert project management and high quality standards make us the ideal partner for biopharmaceutical businesses searching for dependable buffer and process solutions outsourcing.
A&C has a state-of-the-art GMP manufacturing facility in Ireland dedicated to biological buffer manufacturing and production of process solutions, cleaning solutions, chemical blends and WFI. The Irish facility is ISO 9001:2015 certified and is the only in the country to manufacture biological buffers with Water for Injection.
We also offer GMP repacking and down-packing of liquids and powders in batch specific sizes conceived and designed to meet our customers’ requirements.
- Single use bio process bags
- Plastic drums HDPE (various formats)
- Stainless steel drums (various formats)
- Smaller sample packaging available
- IBCs