Onyx Scientific has made a strategic investment to position the company for a commercial API license. The investment will see Onyx expand its UK facility, putting in place the infrastructure to take customers’ projects from concept right the way through to commercialization.
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 license 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 our facilities in North Carolina & India which offer larger scale manufacturing capability.
“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 commercialization,” Denise Bower, commercial director at Onyx Scientific, said. “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 license in place we can respond to customers’ growing requirements for quick set-up and fast turnaround of products on a bespoke basis.”
With specific expertise in development chemistry and solid-state chemistry, the company currently provides clients with early phase API production services under current GMP regulations.