GMP Manufacturing

//GMP Manufacturing
GMP Manufacturing 2018-05-17T00:24:26+00:00
gmp manufacturing
Single-Use Bioreactor Image

Flexible. State-of-the-Art Biologics Manufacturing

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:

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 cGMP guidelines

  • 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

  • Minimal Upstream product change over requirements, utilizing single-use technology