Novavax Contracts to Expand Adjuvant Production

Novavax, a late-stage biotechnology company developing the NVX-CoV2373 coronavirus vaccine candidate against SARS-CoV-2 has secured two manufacturing agreements for large-scale GMP (good manufacturing practice) manufacture of components of the vaccine candidate.

NVX CoV2373 is engineered from the genetic sequence of SARS CoV 2 and was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein; the vaccine contains the company’s saponin-based Matrix-M adjuvant designed to enhance the immune response and stimulate high levels of neutralizing antibodies. A Phase I clinical trial was initiated in May 2020.

The PolyPeptide Group, a contract development and manufacturing organization (CDMO) with facilities in Belgium, Sweden, France, India, and the United States, announced on June 4, 2020 that it will produce two key intermediates used in the production of Matrix-M, the adjuvant component of the vaccine. The company produces proprietary and generic GMP-grade peptides for the diagnostic, cosmetic, pharmaceutical, and biotechnological market.

Seattle, WA-based AGC Biologics announced on June 3, 2020 that it also will manufacture Matrix-M. The company said in a press statement that it will optimize process development for scaled-up production of Matrix-M to increase Novavax’ capacity to deliver doses in 2020 and 2021.
On May 27, 2020, Novavax announced the acquisition of a biologics manufacturing facility and associated assets in Bohumil, Czech Republic, from Praha Vaccines a.s., part of the Cyrus Poonawalla Group, for $167 million. The acquisition includes a 150,000-sq.-ft. vaccine and biologics manufacturing facility including Biosafety Level-3 (BSL-3) capabilities.

The company expects the facility to produce more than one billion doses of antigen annually starting in 2021. In a press statement, the company said it plans to expand antigen capacity in the US and Asia and increase production of Matrix-M to match antigen capacity at multiple sites globally.

The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX CoV2373.

Sources:

The PolyPeptide Group ACG Biologics Novavax