Onyx Scientific makes strategic investment in commercial API licence

Investment fills the growing gap in the market for manufacturers that have the niche capabilities to deliver small-scale commercial API projects.

As part of the initiative, Onyx will invest in implementing Quality by Design (QbD) and Design of Experiments (DoE) principles into its API development and manufacturing practices, establishing critical quality parameters for every product. The company will also expand its team of scientists, as well as its analytical and quality assurance (QA) teams.

Onyx has engaged with the Medicines and Healthcare Products Regulatory Agency (MHRA) from the initial stages of its move to commercial manufacture. Following the licence approval, which is expected later this year, the UK facility will have the capacity to manufacture low volumes of drug substance, particularly for orphan drugs. This new service will complement the company's facilities in North Carolina and India, which offer larger scale manufacturing capability.

Denise Bowser, commercial director at Onyx Scientific, said: “Onyx has built a great reputation in the market for helping drug developers to deal with complex chemistry and deliver early-stage programs that enable them to progress their candidates. It’s an important milestone in the growth for our UK facility to be able to support customers in taking projects through to full commercialisation.

“There is a growing gap in the market for manufacturers that have the niche capabilities to deliver small-scale commercial API projects. We want to fill that space and remove the need for our customers to seek other partners to help them manufacture their drug substance commercially. With our commercial licence in place we can respond to customers’ growing requirements for quick set-up and fast turnaround of products on a bespoke basis.”