Oncobiologics opens commercial launch manufacturing facility in Cranbury, New Jersey

CRANBURY, N.J., May 4, 2015 /PRNewswire/ -- 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 utilize multiple technologies that enable rapid deployment of flexible manufacturing at commercial scale.  Through the use of the latest 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 significant flexibility in meeting global market demand for its biosimilar portfolio.

Scott Gangloff, Oncobiologics' Senior Vice President of Development and Manufacturing, commented, "The completion of our Biologics Manufacturing Center is a watershed achievement for Oncobiologics, representing the final piece of the BioSymphony business model that we have assembled over the past three years.  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."

Oncobiologics Founder & CEO, Pankaj Mohan, Ph.D., 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 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.

About Oncobiologics, Inc. and BioSymphony™ Model
Oncobiologics is a privately-held biopharmaceutical company focused on the advancement of its pipeline of 11 biosimilar products, two of which are currently in clinical development.  Led by a team of biopharmaceutical experts, Oncobiologics operates from a state-of-the-art 50,000 sq. ft. fully-integrated R&D and manufacturing facility in Cranbury, NJ.  The company employs its BioSymphony™ biosimilars business model to achieve accelerated development and technical excellence in order to create affordable medicines for patients around the world. The aggregate market value at time of patent expiry for the molecules in Oncobiologics' pipeline is projected to be in excess of $100 Billion.

For more information, please visit www.oncobiologics.com

Forward Looking Statements
The scientific information in this news release related to pipeline products is preliminary and investigative.  These potential products are not approved by the U.S. Food and Drug Administration or any other regulatory body, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

SOURCE Oncobiologics, Inc.

Related Links

http://www.oncobiologics.com