Gallus BioPharmaceutical Aquires CMO Laureate Biopharmaceutical Services
he CMO Gallus BioPharmaceutical has acquired the biologics CMO Laureate Biopharmaceutical Services.
Gallus BioPharmaceuticals, a St. Louis-based CMO has acquired Laureate Biopharmaceutical Services, a biologics CMO located in Princeton, New Jersey. This acquisition doubles Gallus’ process development and clinical drug-substance-manufacturing capacity and adds full protein characterization, testing, and clinical fill-finish capability. With the acquisition, Gallus has two centers of excellence. The Princeton site is a Center of Excellence for process development and manufacture of clinical-stage products, including fill-finish, and the St. Louis site is a Center of Excellence for process development and clinical and commercial manufacture of biopharmaceutical products.
Gallus has clinical and commercial suites at both sites, with 50-L to 2000-L GMP single-use platforms from Xcellerex and HyClone in addition to 50-L to 2000L fixed and flexible stainless-steel bioreactors and associated downstream purification for drug substances.
Source: Gallus BioPharmaceuticals
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.
