SUPPORTING CHEMICAL SYNTHESIS FACILITY

本合同将为合同HHSN275201700003C化学合成设施提供与NICHD材料、设备和文件相关的运输和手续费支持。 避孕研究处(CRB)支持合成和测试广泛的男性和女性避孕药的研究。几十年来，成功地为男性和女性开发新的避孕方法一直是一个目标。自该计划开始以来，CRB一直需要一种化学合成设施(CSF)，能够从实验室克规模合成潜在的抗生育药物到相对较大的公斤规模。千克规模的化学制剂是根据当前的良好制造规范(CGMP)生产的，用于全面的避孕评估，包括毒理学研究和临床前安全性研究，然后再进入人体临床研究。 CSF向政府提供化学品、化学中间体、类固醇、候选药物和药物，这些要么是商业上无法获得的新化学实体(NCE)，要么是商业获取的过于昂贵的化学实体。脑脊液的化学合成领域包括小分子拮抗剂或蛋白质靶标激动剂，包括但不限于活性天然产物、天然产品类似物、活性类固醇雌激素、孕激素、雄激素及其类似物。此外，脑脊液在支持合成许多非天然氨基酸的中间体方面发挥着重要作用，这些氨基酸可能会被另一家CRB承包商纳入到非天然多肽激动剂或拮抗剂的制备中。

This contract is to provide support on shipping and handling charges associated with NICHD materials, equipment, and documentation for Contract HHSN275201700003C Chemical Synthesis Facility. The Contraception Research Branch (CRB) 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 CRB has had a continuing need for a Chemical Synthesis Facility (CSF) capable of synthesizing potential anti-fertility agents on a laboratory 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 antagonist or agonists of protein targets including but not limited to active natural products, natural product analogues, active steroids estrogens, progestogens, 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 CRB’s contractor.