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The move was made to meet an upsurge in Phase I/II GMP campaigns from clients in Europe and the United States.
Onyx Scientific, a contract research organization (CRO) based in the United Kingdom, announced plans to expand its GMP space following an increase in demand for its small scale API manufacturing services. This latest venture includes an investment to install a new class 100,000 suite at its facility in North East England. The move was made to meet an upsurge in Phase I/II GMP campaigns from clients in Europe and the United States.
Onyx Scientific specializes in preclinical and clinical development projects and expansion plans were given the go ahead at the CRO’s site following a successful audit by the Medicines and Healthcare products Regulatory Agency (MHRA) in February 2015. Onyx Scientific produces API under current GMP regulations, which dovetails its earlier stage custom synthesis, lead optimization, solid state and analytical services.
According to Denise Bowser, commercial director at Onyx Scientific, in a press release, “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,” stated Bowser. “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.”
Onyx Scientific made significant investment in 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. The company works with many specialty drug development firms and biotech organizations across the globe, helping to accelerate candidates from discovery to production.
Source: Onyx Scientific