Onyx Scientific will position itself for a commercial active pharmaceutical industry (API) license after seeing industry demand for flexible, specialist, and small-scale API manufacturing. With this investment, Onyx will also expand its UK facility to boost its infrastructure.
Currently, Onyx provides early phase API production services under current good manufacturing practice (GMP) regulations, but with this license it will be able to produce APIs for commercial use as its customers move their drugs to market.
Denise Bowser, commercial director at Onyx, said in a statement, “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.”
Bowser added that, with its customer license in place, the company will be able to fulfill its customers’ requirements for “fast turnaround of products on a bespoke basis.”
From its initial stages of moving into the commercial manufacturing space, Onyx has worked with the Medicines and Healthcare Products Regulatory Agency and, once its license is approved, the UK facility will be able to manufacture low volumes of drug substances.
Onyx stated that it expects its API license to be approved later in 2019, with the UK facility set to produce drug substances for orphan drugs. The company said that the services provided at the plant will complement its facilities in North Carolina, US, and at its Indian sites, which offer large-scale manufacturing.
The company will also work to implement ‘quality by design’ and ‘design of experiments’ principles into its API development and manufacturing practices.
Additionally, Onyx stated that it will expand its team of scientists and analytical and quality assurance teams with this investment.