Reagent Proteins is the leading global supplier of preclinical and cGMP grade CRM197, a non-toxic mutant of diphtheria toxin that is used as a carrier protein for polysaccharides and haptens making them immunogenic. We ensure that development scientists and manufacturing supply chain professionals are provided with ready access to sufficient supplies of pre-clinical and cGMP grade CRM197 from milligrams to kilograms throughout the development and commercialization of their product. The Reagent Proteins CRM197 is supported by a Biologics Master File (BMF) filed with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).
A Biologics Master File is a confidential, detailed dossier submitted to the FDA which contains the proprietary information on the manufacture and safety of a drug component. Reagent Proteins will submit a letter authorizing FDA to review the CRM197 BMF in conjunction with their review of a customer-filed IND using Reagent Proteins CRM197 as a critical intermediate component in the manufacture of their product(s). Reagent Proteins will also provide a copy of this authorization letter to each customer for inclusion in their IND. Since the BMF mechanism is not available in the EU or elsewhere in the world, Reagent Proteins will supply the necessary information regarding the CRM197 required to complete our customer’s regulatory filings. This information will be supplied in a format consistent with CTD Module 2 and Module 3, to be easily incorporated into non-US regulatory filings.