CHEMICAL SYNTHESIS FACILITY

避孕发展方案（CDP）支持广泛的男性和女性避孕药物的合成和测试研究。成功开发新的男女避孕方法是几十年来的一个目标。从这个项目开始，CDP就一直需要一个化学合成设施（CSF），能够从实验室的毫克到克的规模合成潜在的抗生育剂，到相对较大的公斤的规模。千克级化学制剂是根据现行的良好生产规范（cGMP）生产的，用于全面的避孕评估，包括进入人体临床研究之前的毒理学研究和临床前安全性研究。

The Contraceptive Development Program (CDP) supports research in the synthesis and testing of a broad spectrum of male and female contraceptive agents. Successful development of new contraceptive methods for men and women has been a goal for many decades. From the inception of this program, the CDP has had a continuing need for a Chemical Synthesis Facility (CSF) capable of synthesizing potential anti-fertility agents on a laboratory milligram to gram scale to a relatively larger kilogram scale. The kilogram scale chemical agents are manufactured under current Good Manufacturing Practices (cGMP) for comprehensive contraceptive evaluation, including toxicology studies and preclinical safety studies before entering human clinical studies. The CSF provides the Government with chemicals, chemical intermediates, steroids, drug candidates, and drugs, which are either a new chemical entity (NCE) commercially unavailable or unduly expensive to obtain commercially. The areas of chemical synthesis for CSF consist of small molecule antagonists or agonists of protein targets, including but not limited to active natural products, natural product analogues, active steroids estrogens, progestins, androgens, and their analogues. In addition, CSF has an important role in support of providing intermediates for the synthesis of many unnatural amino acids that may be incorporated into the preparation of unnatural peptide agonists or antagonists by another CDP's contractor.