The Biological Response Modifiers Program (BRMP) has the responsibility for preclinical and early clinical evaluation and development of a wide variety of biological response modifiers (BRMs) with potential for cancer therapy. An important aspect of this responsibility is the procurement, processing and quality assurance testing of various GLP and GMP BRMs for preclinical and clinical investigations. The purpose of this contract will be to provide effective management of these functions for the BRMP. The Contractor will be responsible for the production, processing and quality assurance testing of biologic agents. Quality assurance and control testing involves specific assays for sterility, pyrogenicity, endotoxin levels, general safety testing and preclinical studies related to the development of a safe dose and route of administration. The Contractor will also be responsible for purification, vialing, labeling, potency and purity testing of biologics obtained in bulk form for laboratory or clinical use. In some instances, production or conjugation of biologics, such as monoclonal antibodies or vaccines for preclinical laboratory use or clinical trials will also be performed. All procedures will conform to the Food and Drug Administration specifications for the development of biologics and will be in compliance with Government regulations for human use products. The Contractor will also be responsible for assisting with the development of master drug files and investigational new drug (IND) applications on biologics produced by the Contractor for the NCI.
