CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs, CMOs, and suppliers in COVID-19 projects featuring Catalent, Fujifilm, PolyPeptide Group, Dyadic International, and SiO2 Material Science.
Chemical/Chemical API Manufacturing
Novavax Selects PolyPeptide to Manufacture COVID-19 Vaccine Adjuvant
The PolyPeptide Group, a Malmö, Skåne, Sweden-headquartered CDMO, has partnered with Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, on large-scale GMP production of a component of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373.
PolyPeptide Group will produce two key intermediates used in the production of Matrix-M, the adjuvant component of the vaccine, which is being used to enhance the vaccine’s immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology.
Source: Polypeptide Group
Dyadic Selected to Develop Cell Lines for COVID-19 Vaccine Candidates
Dyadic International, a Jupiter, Florida-based biopharmaceutical company, has been selected by the Frederick National Laboratory to engineer its patented and proprietary C1 cell lines to produce a number of COVID-19 vaccine candidates that will be used by the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases, at the National Institutes of Health.
The Frederick National Laboratory is a Federally Funded Research and Development Center sponsored by the National Cancer Institute and currently operated by Leidos Biomedical Research.
Dyadic is developing a biopharmaceutical gene-expression platform based on the fungusthermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus-like particles and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins.
Source: Dyadic International
Catalent, Spicona in Pact to Develop COVID-19 Vaccine Candidate
Catalent has signed an agreement with Spicona, a New York-based company focused on research and development in the field of immunology and vaccinology, to develop a virus-like protein (VLP)-based vaccine against COVID-19 using Catalent’s proprietary GPEx cell-line development technology to develop a cell line expressing the recombinant VLP at its Madison, Wisconsin facility.
Catalent’s GPEx technology creates mammalian cell lines with high speed and efficiency that may be applied from early feasibility studies to clinical manufacturing to commercial-scale production.
Spicona’s pipeline is being built around compounds for the prevention and treatment of infectious diseases, with an immediate focus on the development of a safe and protective COVID-19 vaccine.
Catalent’s Madison facility provides mammalian cell-line development, process development, process validation, formulation development and drug-substance manufacturing ranging from preclinical to commercial stage. The site recently commenced an expansion to provide additional clinical and commercial production capacity at the 2,000-liter or 4,000-liter batch scale.
Tonix Pharmaceuticals, Fujifilm Partner for COVID-19 Vaccine
Tonix Pharmaceuticals, a New York-based clinical-stage biopharmaceutical company, has entered into an agreement with Fujifilm Diosynth Biotechnologies, a CDMOof biologics and part of Fujifilm Corporation, for its contract manufacturing and development services to support the manufacturing of Tonix’s COVID-19 vaccine candidate, TNX-1800, for clinical trial supply.
Under the agreement, Fujifilm will develop a manufacturing process, manufacture and stock a supply of TNX-1800 at Fujifilm’s College Station, Texas site for Tonix’s clinical development. The company’s manufacturing site in College Station, Texas is designed to operate as a contract manufacturing facility to support production on multiple scales as candidates move through the clinical process from clinical stages into commercialization.
In February 2020, Tonix announced a strategic collaboration with Southern Research to support the development of TNX-1800 (live horsepox virus vaccine for percutaneous administration) to protect against COVID-19, based on Tonix’s proprietary horsepox vaccine platform. Tonix is developing TNX-801 as a potential smallpox preventing vaccine for the US Strategic National stockpile and as a monkeypox preventing vaccine. The company says it believes that its proprietary horsepox virus has the potential to serve as a vector for vaccines to protect against other infectious agents.
Source: Tonix Pharmaceuticals
SiO2 Receives $143-M Contract from US Government
SiO2 Materials Science, an advanced materials science company, has entered into a $143-million agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense in partnership with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, to accelerate the production scale-up of the company’s patented, primary packaging platform for storing SARS-CoV-2 vaccines and therapeutics.
SiO2’s patented materials science is a combination of a plastic container with a pure glass coating for biological drugs and vaccines.
SiO2 currently employs more than 200 engineers, scientists, and technician in a 165,000-square-foot manufacturing plant in Auburn, Alabama. The company says it expects to hire 200 more.
Source: SiO2 Materials Science