The antitumor agents acquired by Developmental Therapeutics Program have to be converted to a dosage form suitable for human clinical trials. In this regard, this contract makes available a manufacturing facility wherein the promising antineoplastic agents can be formulated, scaled up and converted to dosage forms ranging from ready-to-use injectable vial to a reconstitutable lyophilized dosage form. These agents are produced following FDA mandated cGMPs and other regulatory requirements for human clinical agents.Cancer Therapeutics Evaluation Program (CTEP) uses the clinical agents manufactured by this contractor to support human clinical trials. The clinical agents produced under the RAID initiative will be transferred to the sponsoring investigators for their clinical trials.
