Onyx Scientific prepares for commercial API license with UK facility investment

Onyx Scientific has announced it is investing in a new facility at its UK site in order to prepare for the approval of a commercial API license.

The new facility, which represents a £3m investment, is currently in the design phase and the building work will begin at the start of 2021, in preparation for the license approval. It will enable the CDMO to meet demand for flexible, small-scale drug substance manufacture, supporting customers from the moment a lead molecule is identified, into Phase I studies and through to commercial manufacture.

The facility is expected to be approximately 30,000 square feet and will be used for non-GMP & GMP Phase I – III and commercial API manufacturing.

Following the license approval, the UK facility will have the capacity to manufacture low volumes of drug substance for the commercial market. This new service will complement Onyx’s facility in North Carolina, U.S, which offers larger scale manufacturing capability.

Denise Bowser, commercial director at Onyx Scientific, commented: “At Onyx, our chemists are at the heart of everything we do, and we have built a strong reputation for assisting drug developers with complex chemistry.

“The growth of our UK facility is an important milestone for Onyx and means we can help fill the gap in the market for small-scale commercial API requirements. Here at Onyx, we truly care about our customers and their chemistry, treating every molecule as if it were our own. We are excited that following license approval, our team in the UK will be able to guide our customers through the complete journey to market.”

In addition to the facility investment, Onyx is currently working on a process validation campaign that will be used to support the commercial API license.

The CDMO continues to experience strong growth driven by demand from pharmaceutical companies for its integrated CMC capabilities, combining API development, manufacturing, solid state chemistry and analytical expertise. The 70-strong team plans to add at least 30 extra people to its workforce in the next five years to support its clinical and commercial API manufacturing capabilities.