CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Samsung Biologics, WuXi Biologics, and Hainan Poly Pharm.
Samsung Biologics, Enzolytics in Mfg Pact for COVID-19 Drug
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, and Enzolytics, a Plano, Texas-based drug development company, have signed an agreement under which Samsung Biologics will provide CDMO services to support investigational new drug filings for monoclonal antibodies (mAbs) for treating HIV and SARS-CoV-2, the virus that causes COVID-19.
Under the agreement, Samsung Biologics will provide CDMO services from cell-line development and clinical drug substance and drug-product manufacturing. A stable cell line will be manufactured with support from Samsung Biologics’ R&D Center in San Francisco, California. Its related clinical trial materials will be manufactured at Samsung Biologics’ headquarters in Incheon, South Korea.
Source: Samsung Biologics
WuXi Biologics, BioVaxys Partner for COVID-19 Vaccine, Diagnostic
WuXi Biologics, a contract biologics manufacturer, has completed the synthesis of a recombinant SARS-CoV-2 s-protein for BVX-0320, a COVID-19 vaccine candidate, and CoviDTH, an immunodiagnostic product, from BioVaxys Technology a Vancouver, British Columbia, Canada-based bio/pharmaceutical company.
Both the COVID-19 vaccine and diagnostic are headed for clinical trials, with BioVaxys having begun preparing an investigational new drug filing submission to the US Food and Drug Administration for a combined Phase I/II clinical study of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2, the virus that causes COVID-19.
Under an agreement established in March 2021, WuXi Biologics synthesized high yields of SARS-CoV-2 s-protein for BioVaxys’ preclinical safety study of CoviDTH. The study began last month (September 2021).
Source: BioVaxys Technology
Celsion, Hainan Poly Pharm Expand Mfg Pact for COVID-19 Vaccine
Hainan Poly Pharm, a Hainan, China-based generics manufacturer, and Celsion Corporation, a Lawrenceville, New Jersey-based oncology drug-development company, have announced an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine.
Under the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsion’s COVID-19 vaccine.