Onyx is now licensed to manufacture commercial API from our UK facility

Onyx Scientific increases non-GMP capabilities with CMC facility expansion

Sunderland, UK, 28 March – Onyx Scientific, a leading CDMO in the small molecule space, has completed the second phase of expansion at its state-of-the-art Chemistry, Manufacturing and Controls (CMC) facility in Sunderland, UK.

The investment increases the facility’s capabilities to support its customers in CMC services and adds further strength to Onyx’s UK manufacturing capabilities for non-GMP scale-up by more than 50%.

This new facility consists of four laboratories (each capable of containing four 50L vessels), a separate oven room and dedicated areas for rotary evaporation and large-scale column chromatography area use, typically used to manufacture 3-5 kg batches with suitability for GLP toxicity studies alongside the manufacture of starting materials for GMP processes.

Onyx first opened its state-of-the-art CMC GMP facility in April 2022, doubling the company’s footprint and allowing for expansion of all CMC services, including the introduction of additional GMP facilities that increased capacity for clinical and commercial API manufacturing by 50%.

The first and second phases of the multi-million pound development are now complete and operational with the third and final phase, which includes a brand new analytical laboratory to support the new facility, expected to be completed in Q2 2023.

Denise Bowser, commercial director at Onyx said: “We have seen significant growth in demand for Onyx’s commercial and clinical API manufacturing services. This expansion of our non-GMP facilities complements those services and strengthens our plans for future growth.”

“Onyx continues to focus its expansion on both its facilities and workforce. Over the last 12 months we have expanded the workforce with up to 120 staff. Onyx now enters the next phase of its expansion, which will include a significant investment in world-class solid-state services.”

As a small molecule CDMO with a specialisation in solid-state chemistry, Onyx can assist clients’ API knowledge and early production to current GMP regulations.