GMP Manufacturing

GMP Manufacturing2018-01-03T02:18:48+00:00

Formulation, Fill, & Finish

Our aseptic vial filling and finish line can support you with final product for a variety of your clinical supply needs. We can aseptically fill bulk drug substance manufactured in-house or bulk drug substance shipped to VxP Biologics from client sites. Various vial sizes and primary packaging configurations are available for filling by our highly qualified aseptic fill team.

Capabilities include:

  • Vial sizes: 2ml – 100ml
  • Batch size: 100 – 20,000 vials per run
  • Manual and fully automated filling systems
  • Qualified/Validated Facilities
  • Compliant with US FDA and European requirements
  • Coordinated labeling and shipping to clinical sites

 

Preclinical and GMP Manufacturing

We currently produce preclinical and GMP clinical materials consisting of multiple product types including: Monoclonal Antibodies, Recombinant Proteins, Enzymes, Transgenics, Fragment Antibodies, Fusion Proteins Scaffold Molecules, Vaccines, and products for gene therapy applications.

Facility highlights:

  • Ten separate bioreactor, fermentation, and aseptic manufacturing suites. Viral and non-viral suites are on separate HVAC systems.
  • BSL-3 Capabilities: We can manufacture products under BSL-3 for the production of organisms or toxins requiring high containment.

Our facility is designed to provide flexibility in accommodating numerous manufacturing platforms and customer requirements. One of VxP Biologics unique service offerings is the filling of materials that are considered infectious or toxic. We can perform this filling, within cGMP guidelines, in a separate BSL-3 virus production area with capacities of 200 to 2000 vials per day using a semi-automated process.

 

Contact us today for a free consultation about your Biologics program today.