mAb biosimilar developer builds commercial manufacturing facility in New Jersey
The new facility employs single-use technologies, while the company says that its footprint and associated capital investment is significantly lower than a conventional facility of equivalent capacity.
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.
The design and construction of the facility was completed in less than one year, which is less than half the time required for typical stainless steel-based commercial facilities. The new Cranbury facility also can be rapidly replicated in the future, the company said, which provides it with added flexibility in meeting demand for its biosimilar portfolio.
"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 commercialization," Scott Gangloff, Oncobiologics' Senior Vice President of Development and Manufacturing, said.
Oncobiologics Founder & CEO, Pankaj Mohan, added, " This project is another demonstration of the capital efficiency and speed that we embrace as critical success factors in the emerging mAb biosimilars marketplace.”