Taking the total number of dedicated GMP suites at the company to four
UK-based contract research organisation Onyx Scientific is to invest in expanding 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 Sunderland, UK aimed at satisfying an upsurge in Phase I/II GMP campaigns from clients in Europe and the US.
Onyx Scientific specialises in pre-clinical/clinical development projects and the expansion plans were given the go-ahead following a successful audit by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in February.
Celebrating its 15th birthday this year, the company provides API production up to 50–100 litres under current GMP regulations, which dovetails with its earlier stage custom synthesis, lead optimisation, solid state and analytical services.
Denise Bowser: This latest investment will add a fourth dedicated GMP suite at Onyx Scientific
Denise Bowser, Commercial Director at Onyx Scientific, said this latest investment will bring the total capacity at the company's UK site 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,' she added.
'So by having an additional GMP suite at our disposal, it gives us even greater flexibility to assist our clients who are under increasing timeline pressure to deliver against their development programmes.'
Having an additional GMP suite at our disposal gives us even greater flexibility
This latest expansion follows investment in continuous flow manufacturing in June 2014, which has allowed the company's clients to explore alternatives during product research and development programmes, while overcoming the often time-consuming and costly process of batch manufacturing.
Onyx Scientific has achieved preferred partner status and undertakes 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 specialist drug development firms and biotech organisations, helping to accelerate candidates from discovery to production.
Owned by IPCA Laboratories, the 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.