Member Article

Sunderland chemistry specialist to expand GMP capability

Sunderland-based Onyx Scientific is to invest in growing space intended for good manufacturing practice (GMP) projects, following an increase in demand for its small scale pharmaceutical manufacturing services.

The move will see the installation of a new ‘cleanroom’ suite at its facility, aimed at satisfying an upsurge in GMP campaigns from clients, in Europe and the USA, developing new drug products intended for clinical trials.

Onyx, who specialise in the production of Active Pharmaceutical Ingredients (API) during clinical development projects, have had expansion plans given the go ahead following a successful audit by the Medicines and Healthcare Products Regulatory Agency (MHRA), in February.

Celebrating its 15th birthday this year, the contract research and manufacturing organisation provides clients with the production of API under current GMP regulations, which dovetails its earlier stage specialist chemistry services.

This latest venture by the chemistry specialist follows a significant investment into continuous flow manufacturing last year.

This has allowed its clients to explore alternatives during product research and development programs, while overcoming the often time-consuming and costly process of batch manufacturing.

Onyx Scientific has achieved preferred partner status and undertaken GMP projects for some of the world’s largest pharmaceutical companies and major institutions, such as Cancer Research UK.

The company also works with many specialty drug development firms and biotech organisations across the globe, helping accelerate candidates from discovery to production.

Denise Bowser, commercial director at Onyx Scientific, said: “This latest investment will bring the total capacity at our UK site up to four dedicated GMP suites, which represents a steady but significant growth in this area over the past few years.

“We have worked with hundreds of clients at the small scale non-GMP stage and have been able to provide rapid scale up to GMP for many of them with the same technical team, all under one roof.”

“So by having an additional GMP suite at our disposal, it gives us even greater flexibility to assist our clients that are under increasing timeline pressure to deliver against their development programs.”

The investment has been driven by market demand and adds additional resource to the site, which should lead to the creation of several new chemist roles in the future at Onyx Scientific

Denise added: “As well as attracting new clients through reputation, we are seeing more existing clients returning for GMP work. Often we have supported such clients at an earlier stage in the drug development pipeline and having impressed first time round, they return when they are ready to scale-up for GMP supply.”