Ultrafine expands GMP manufacturing facility
Manchester-based Ultrafine, which provides development services to pharmaceutical and biotech companies, is expanding capacity with a new medium-scale cGMP manufacturing facility to complement its three existing cGMP laboratories and build on the company's success in small-scale synthesis.
Manchester-based Ultrafine, which provides development services to pharmaceutical and biotech companies, is expanding capacity with a new medium-scale cGMP manufacturing facility to complement its three existing cGMP laboratories and build on the company's success in small-scale synthesis.
The new facility will feature two new 200-litre vessels - one Hastelloy and one glass-lined steel; the existing labs operate at 20-50 litre scale.
According to Michael Harris, head of business development, the company has a strong pipeline of early stage compounds and there will now be no need for customers to transfer technologies to another partner to undertake Phase II clinical trials. 'We are small, light and flexible and can rapidly scale processes,' he said.
Ultrafine, which employs some 80 people, has seen its turnover increase by 50% in the last year. It is also looking to expand its laboratory capacity in the next six months from 45 hoods to 70.
The company has successfully completed the first phase of the chemical process development and scale-up of Cambridge Biotechnology's lead compound CBT1008. Selected to enter non-clinical devel-opment for the treatment of neuropathic pain earlier this year, batches of CBT1008 produced by Ultrafine will enable CBT to complete its pre-clinical studies. Ultrafine will then go on to manufacture the compound for use in clinical trials, having conducted extensive process development work to establish a scalable route.
Ultrafine has recently entered into an expanded agreement with emerging UK speciality pharmaceutical company Arakis, to whom it will provide early phase GMP manufacturing.