CHEMICAL SYNTHESIS FACILITY

避孕药具开发方案（CDP）支持合成和测试广泛的男性和女性避孕药的研究。成功开发男女新的避孕方法是几十年来的一个目标。从该计划开始，CDP就一直需要一个化学合成设施（CSF），能够在实验室毫克到克的规模上合成潜在的抗生育剂， 更大的公斤级。公斤级化学制剂是根据现行的良好生产规范（cGMP）生产的，用于全面的避孕评价，包括毒理学研究和进入人体临床研究之前的临床前安全性研究。 CSF向政府提供化学品、化学中间体、类固醇、候选药物和药物，这些化学品或者是商业上无法获得的新化学实体，或者是商业上获得过于昂贵的化学品。CSF的化学合成领域包括蛋白质靶标的小分子拮抗剂或激动剂，包括但不限于活性天然产物、天然产物类似物、活性类固醇雌激素、孕激素、雄激素及其类似物。此外，CSF在支持为药物提供中间体方面具有重要作用。 许多非天然氨基酸的合成，这些非天然氨基酸可以被另一个CDP的承包商掺入到非天然肽激动剂或拮抗剂的制备中。

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.