Onyx Scientific expands small molecule CMC services with new UK facility

The contract development and manufacturing organisation (CDMO) has completed the first phase of its multi-million-pound development. 

The new facility, located near the company’s headquarters in Sunderland, UK, doubles Onyx’s current footprint and allows for expansion of all Chemistry, Manufacturing and Controls (CMC) activities. The site has received GMP certification and commercial manufacturing approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).  

Onyx Scientific specialises in process chemistry, preclinical process R&D and small molecule API manufacturing. It has facilities in the UK and one in the US, which provides GMP manufacturing services.  

This new site is the first phase of a multi-million-pound development, which is expected to be complete by the end of 2022.   

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 programs. 

‘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.’ 

In late 2020, Onyx Scientific announced that it was investing in a new £3 million facility at its UK site in order to prepare for the approval of a commercial API license. It was granted this license in June 2021, which allowed the company to support API projects from pre-clinical studies to low volume commercial manufacture.