The purpose of this contract is to provide effective management of these functions for the BRMP. The contractor shall be responsible for receipt, dispensing, storage, distribution and inventory control of biologic agents. Quality assurance and control evaluation which involves specific assays for sterility, pyrogenicity, endotoxin levels, general safety testing and preclinical studies related to safe dose and route of administration. The contractor shall be responsible for processing, vialing, labelling, potency and purity testing of biologics obtained in bulk form for clinical use. In some instances production and initial purification of biologics, such as monoclonal antibodies for clinical trails is performed.
