CMC Biologics and OncoSynergy Form Pact
CMC Biologics and OnoSynergy form an agreement from cell-line development.
CMC Biologics and OncoSynergy have entered into an agreement for cell-line development, process development, analytical development, and manufacturing of non-GMP material to enable early toxicology testing and cGMP material for investigational new drug enabling toxicology studies and Phase I clinical trials. This work will advance OncoSynergy’s OS2966 monoclonal antibody program based on its “targeted synergy” approach–a strategy allowing broad inhibition of multiple fundamental cancer-growth mechanisms with a single drug. The project will be executed by CMC Biologics at its Copenhagen development and manufacturing facility. OncoSynergy EU SAS in France will lead the project.
Source: CMC Biologics
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
