Licence approval from the MHRA is expected this year and will see the British CRO take customers’ projects from concept to market
Onyx Scientific, the CRO based in Sunderland (UK), said it has made a strategic investment to position the company for a commercial API licence.
“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," said Denise Bowser, Commercial Director at Onyx Scientific.
The move, Onyx said, is driven by growing demand for flexible, specialist and small-scale API manufacture. The amount of the investment has not been disclosed, but the company said the investment will serve to expand its UK facility, putting in place the infrastructure to take customers’ projects from concept right the way through to commercialisation.
We want to remove the need for our customers to seek other partners to help them manufacture their drug substance commercially
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 the analytical and quality assurance (QA) teams.
Onyx said it 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 Onyx's facilities in North Carolina (US) and in 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 commercialisation," Bower concluded.