SYNTHESIS OF NON-GMP SMALL MOLECULES Base Year Increment 2

药品资源部门（NCI/DCTD/DTP/PRB）要求承包商提供所需的服务、人员、设备和设施，以在cGMP条件下进行原料药的工艺开发和合成。要合成的给定材料的数量可以从数克到数公斤不等。这些材料需要通过定义明确和经过验证的化学工艺制造，具有高纯度，并具有良好的特性。它们旨在用于配方开发、药理学和毒理学研究以及临床试验。合同工作范围的主要方面将包括：(1)cGMP工艺开发，将实验室规模的程序转变为强大且可重复的大规模工艺；(2)根据需要合成多克至多公斤的原料药/药品；(3)为保证所制备化合物的纯度、鉴别和质量而进行的分析，包括cGMP批次的QA/QC；(4)根据需要进行溶解度/稳定性等其他研究。与基准年增量1相同。

The Pharmaceutical Resources Branch (NCI/DCTD/DTP/PRB) requires a contractor that will provide services, personnel, equipment, and facilities as required to perform process development and synthesis of bulk materials under cGMP conditions. The quantity of a given material to be synthesized may range from multiple grams to multiple kilograms. These materials are required to be manufactured via well-defined and validated chemical processes, to be of high purity, and to be well-characterized. They are intended for use in formulation development, pharmacology and toxicology studies, and clinical trials. Major aspects of the contract work scope will include: (1) cGMP process development to transform laboratory-scale procedures to a robust and reproducible large-scale process; (2) synthesis of bulk chemicals/drugs on multi-gram to multikilogram scale as needed; (3) analysis for ensuring the purity, identity, and quality of the prepared compounds including QA/QC for the cGMP batches; and (4) additional studies such as solubility/stability as needed. Same as Base Year Increment 1.