Oncobiologics Completes Construction of mAb Mfg Facility
Oncobiologics, Inc.,a biotherapeutics company focused on developing and commercializing monoclonal antibody (mAb) biosimilars, has completed the construction of its GMP commercial launch manufacturing facility at its headquarters in Cranbury, New Jersey.
The Cranbury facility is designed to use multiple technologies to enable flexible manufacturing at commercial scale. Through the use of the single-use technologies, the facility footprint and associated capital investment is significantly lower than a conventional facility of equivalent capacity. The design and construction of the facility was completed in less than one year, which is less than half the time required for stainless steel-based commercial facilities. Previously, Oncobiologics' in-house clinical manufacturing facility was constructed and validated in less than six months. The new Cranbury facility can be rapidly replicated in the future, thus providing Oncobiologics with flexibility in meeting global market demand for its biosimilar portfolio.
The new commercial 2000-L 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' eleven mAb biosimilar candidates have entered the clinic within the past year.