CDMO 3P selected to scale-up microbial production for Aussie biotech
Under terms of the deal – financials of which were not disclosed – the contract development and manufacturing organisation (CDMO) will make preclinical batches of an innovative immunotherapy on behalf of Ondek.
The unnamed product uses Ondek’s Helicobacter pylori technology which will be transferred to 3P’s facility in Navarra, Spain where scale up and non-GMP manufacture under anaerobic conditions will occur.
“We are currently performing the process at 10L in a Biostat B glass fermenter from Sartorius, and the process will be scaled-up to 100L in a SS316L Fermenter,” 3P spokeswoman Edurne Gil told Biopharma-Reporter.
“The key aspect of the process is assuring an anaerobic environment in a fermenter design for aerobic organisms.” Further details of the manufacturing process and the product itself were not disclosed.
However, 3P’s 4,500m2 facility combines stainless steel with single use technologies “as much as posible,” Gil said.“We apply stainless steel technologies in those operations where the integrity of the equipment is very important due to the operational parameters described in the manufacturing procedure.”
According to Ondek, its technology harnesses the immune regulatory properties of the bacterium to develop products that are easily and safely administered for improved management of allergic and inflammatory diseases.
So far the firm has announced one product, ImmBALANCE, in development of a range of products for the management of allergic indications.
