Commercial manufacturing approval has been granted by the MHRA for the site
Onyx Scientific, a small molecule API CDMO, has announced the opening of a second facility in Sunderland, UK.
The site, located close to Onyx’s UK headquarters, doubles the company’s current footprint and allows for expansion of all chemistry, manufacturing and controls (CMC) activities, including the introduction of additional GMP facilities to increase capacity for commercial API manufacturing by 50%.
The first phase of the development is now complete and operational with GMP certification and commercial manufacturing approval from the Medicines and Healthcare Products Regulatory Agency (MHRA).
Denise Bowser, Commercial Director at Onyx, said: “We are delighted to announce the opening of our new facility in Sunderland. Onyx continues to experience strong growth, driven by the consistent demand from biotech and pharmaceutical companies for integrated early-phase development programmes.
“Our customers recognise the benefits of retaining drug substance activities with one partner and our capability in taking projects from candidate selection to, where appropriate, commercial supply.
“This expansion cements our position as a leading provider of integrated CMC services and drug substance supply and allows us to continue to deliver the exceptional service that we are known for.”
The company has seen its workforce grow by 40% to 100 staff this financial year and it expects a further increase of 50% in the next three years. The final two phases of the development are expected to be complete by the end of 2022.