GMP Manufacturing Platform

Oncobiologics operates a GMP manufacturing facility to support 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:

Manufacturing Capability

  • Manufacturing flexibility, achieved through single-use technology allowing for 200L and 2000L upstream production capabilities
  • State of the art facility encompasses viral segregated Purification suites, following cGMPguidelines
  • Operational proficiency to perform campaign-based cell banking operations with controlled rate freezes
  • Single-Use Bioreactors can be modified rapidly to match an existing or new process design with little to no impact to the operational timelines
  • Planned future expansion and increase in capability to meet global demand while minimizing idle capacity
  • Facility can be replicated globally to address supply chain needs
  • EMA & FDA Approved Partners for Prefilled Syringe and Vial Fill

Low Production Costs by Design

  • Significant lower capital investment relative to stainless steel facilities
  • Minimal Upstream product change over requirements, utilizing single-use technology
  • Reduced Cleaning and Sterilization validation, utilizing single-use technology