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CRO to Expand GMP Capability

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UK-based Onyx Scientific is to invest in growing its GMP space following an increase in demand for its small scale API manufacturing services.

The move will see the installation of a new Class 100,000 suite at its facility in North East England aimed at satisfying an upsurge in Phase I/II GMP campaigns from clients in Europe and the USA.

Onyx Scientific specializes in pre-clinical/clinical development projects and expansion plans were given the go ahead at the contract research organization (CRO) following another successful audit by the MHRA in February.

Celebrating its 15th birthday this year, the CRO provides clients with the production of API up to 50l-100l under current GMP regulations, which dovetails its earlier stage custom synthesis, lead optimization, solid state and analytical services.

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.”

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 organizations across the globe, helping accelerate candidates from discovery to production.

The CRO’s team has built a strong reputation for dealing with some of the most complex early stage chemistry challenges for companies developing new compounds.

The IPCA Laboratories-owned CRO assists companies with medicinal chemistry through Phase I-III. The UK site is then able to scale-up, tech transfer and increase efficiency using its parent company’s large scale API manufacturing sites in India.