Oncobiologics opens commercial launch manufacturing facility in Cranbury, New Jersey
Will manufacture products at commercial scale quickly and efficiently
Oncobiologics, a privately held biotherapeutics company developing and commercialising monoclonal antibody (mAb) biosimilars, has completed construction of its GMP commercial launch manufacturing facility at its headquarters in Cranbury, New Jersey, US.
The facility will use multiple technologies, including single-use, to manufacture products at commercial scale quickly and efficiently. It can also be rapidly replicated in the future, providing the company with the flexibility to meet global market demand for its biosimilar portfolio.
Scott Gangloff, Oncobiologics' Senior Vice President of Development and Manufacturing, said: 'The completion of our Biologics Manufacturing Centre is a watershed achievement for Oncobiologics. By fully-integrating our CMC development and manufacturing operations at a single site, we are able to expedite technology transfer, resulting in a streamlined path to commercialisation.'
Oncobiologics' Founder & CEO, Pankaj Mohan, added: 'The Oncobiologics team has designed and built a world-class facility in record time. This project is another demonstration of the capital efficiency and speed that we embrace as critical success factors in the emerging mAb biosimilars marketplace. The collaborative integration between critical functional areas enables us to rapidly advance high quality mAb biosimilar candidates, which is proving to be an important differentiator for Oncobiologics.'
The new commercial 2000L facility has already been deployed to manufacture ONS-3010, a Humira/adalimumab biosimilar candidate, for use in an upcoming Phase III clinical trial. Two of Oncobiologics' 11 mAb biosimilar candidates have entered the clinic within the past 12 months.
