To develop the chemistry and provide GMP synthesis of API for Phase I trial
The UK’s leading cancer charity has awarded a major drug development and manufacturing project to chemistry expert Onyx Scientific.
Cancer Research UK has selected the Sunderland, UK-based active pharmaceutical ingredient (API) manufacturer to develop the chemistry and perform the GMP synthesis of the API for use in a Phase I clinical trial.
The team at Cancer Research UK initially approached its preferred suppliers with its requirements and a proposed development route. After analysing the charity’s needs in more detail, the technical team at Onyx Scientific has improved the synthetic methodology as well as suggesting an alternative route, which will potentially help make the project more efficient and cost effective.
Dr Nigel Westwood, drug supply manager at Cancer Research UK, said: ‘Having had a very positive experience of using Onyx Scientific’s process development and GMP manufacturing services in the past, they seemed like a strong candidate for this important project.
‘Despite the fact that Cancer Research UK had to change suppliers at such a critical stage, Onyx Scientific still expects to bring the project in on time and on budget. Given the company’s expertise in chemistry and ability to deliver, we believe it is a perfect fit for the project,’ added Westwood.
Onyx Scientific provides outsourced facilities and expertise to help pharmaceutical and biotech companies accelerate drug candidates from discovery, through development, into Phase I/II GMP API manufacturing. The Cancer Research UK project is one of the biggest in the firm’s history and is expected to take around seven months to complete.
Denise Bowser, commercial director at Onyx Scientific, said: ‘We are delighted to be working again with the team at Cancer Research UK on this major project as it clearly indicates confidence in our technical expertise, customer service and ability to deliver on time.’