AGC Biologics, a global biopharmaceutical CDMO, announced it has expanded its partnership with Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases. AGC Biologics is currently preparing to manufacture Matrix-M™, the adjuvant component of Novavax’ coronavirus vaccine, NVX-CoV2373, from its facility in Copenhagen. AGC Biologics will now expand supply of Matrix-M adjuvant for the vaccine from its facility in Seattle to ensure supply for the United States.
NVX-CoV2373 is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to enable Novavax’ ability to deliver significant worldwide supply in 2020 and 2021.
“We are extremely proud that Novavax has asked us to expand our production of its coronavirus vaccine, NVX-CoV2373, in Seattle,” says AGC Biologics’ CBO Mark Womack. “This enables us to further support Novavax’ need to move this vaccine forward with extraordinary urgency.”
“We are pleased to expand our partnership with AGC Biologics into the United States. They have established themselves as a critical partner in our supply chain of adjuvant for NVX-CoV2373, and we are grateful for their high level of commitment and flexibility in meeting the urgent demands of this project,” says Timothy J. Hahn, SVP, Process Technology at Novavax.
“We are very happy to have the opportunity to serve Novavax at another facility in our global network and to be able to do even more in the fight against the coronavirus pandemic,” says AGC Biologics’ CEO Patricio Massera.
AGC Biologics’ global network spans three continents, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy and Chiba, Japan. Their best in class services include development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells.
Novavax, Inc. is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
About AGC Biologics:
AGC Biologics is a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 1,300 employees worldwide. AGC Biologics has decades of experience in CDMO development and manufacturing, including providing commercial market supply with FDA, PDMA and EMA approvals.
AGC Biologics offers deep industry expertise and unique customized services. Integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression, including the proprietary CHEF1® Expression System for mammalian production.
AGC Biologics is committed to continuous innovation and offers the technical creativity to solve clients’ most complex challenges, including specialization in fast-track projects for orphan drugs and rare diseases.