GMP Manufacturing Platform

Oncobiologics operates a GMP manufacturing facility to support our clinical programs and commercial launches. The facility utilizes the latest single-use technologies from vial to vial, enabling a highly efficient small-footprint facility.  The facility received Qualified Person (QP from Europe) approval in December 2013.  Highlights include:

State-of-the-art Single-Use Technology

  • Minimizes manufacturing footprint
  • Reduces utility requirements

10,000 sq. ft. clean rooms: 

  • 2000-L Bioreactor with Viral Segregated Purification Suites (expanding to 3x2000-L)

Construction Time:

  • 3-4 months (traditional facilities take 3-5 years)

Other:

  • Facility can be replicated globally to increase capacity
  • Ability for rapid expansion allows for certainty of forecasting and minimizes idle capacity
  • EMA & FDA Approved Partners for Prefilled Syringe and Vial Fill