Development of new process increases upstream process yields 100-fold and offers a clear path forward to producing suitable GMP material for human clinical trials
Cobra Biologics, the clinical and commercial manufacturer of biologics and pharmaceuticals, and Novolytics, a biotechnology company developing anti-infective products, have achieved a breakthrough in the development of two Staphylococcus aureus-based phage products for Phase I clinical trials with a 100-fold increase in upstream process yields.
An existing process was transferred to Cobra’s phage team and a scope of work undertaken to further develop the process to increase yields for the two Staphylococcus aureus-based phage products. The controlled, high yield process provides Novolytics with a clear path forward to producing suitable GMP material for human clinical trials.
The worldwide emergence of ‘superbugs’ such as MRSA has coincided with the virtual drying up of new antibiotic drug development. Novolytics aims to lead the way in utilising nature’s own natural antidote, bacteriophages. The company’s lead product, NOVO12, is a phage cocktail administered as a gel for topical treatment of MRSA infections.
Cobra is set to present its methodology, approach, and acquired expertise in phage manufacture at the Phages 2013 conference taking place in Oxford, UK, in September 2013.
‘It is very exciting to be engaged with such novel phage products and to be actively assisting pioneering companies like Novolytics to introduce ground-breaking anti-infectives,’ said Peter Coleman, CEO of Cobra Biologics. ‘The phage team has considerable experience in developing processes for such novel products and looks forward to working closely with Novolytics.’
Novolytics CEO John Hardcastle added: ‘Cobra is helping Novolytics to produce bacteriophage cocktails that remain therapeutically active when produced to GMP standard and on an industrial scale. This is a critical factor for successful exploitation of the exciting potential that phage therapy offers.’