SYNTHESIS OF NON-GMP SMALL MOLECULES Base Year Increment 2

非 GMP 小分子的合成 基准年增量 2

• 批准号: 10936907
• 负责人: James D Talton
• 金额: $ 23.45万
• 依托单位: ALCHEM LABORATORIES CORPORATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-05 至 2023-06-04
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10936907
• 关键词: SYNTHESIS; NON; GMP; SMALL; MOLECULES

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.

药品资源分支机构（NCI/DCTD/DTP/PRB）需要一个承包商，该承包商将根据CGMP条件下提供服务，人员，设备和设施的服务，以执行流程开发和合成批量材料。要合成的给定材料的数量可能从多克到多公斤。这些材料必须通过定义明确且经过验证的化学过程制造，以具有很高的纯度，并且要经过良好的特征。它们旨在用于制定开发，药理学和毒理学研究以及临床试验中。合同工作范围的主要方面将包括：（1）CGMP流程开发将实验室规模程序转换为强大且可重复可重复的大规模过程； （2）根据需要，在多克将大量化学药品/药物合成到多功能图； （3）分析用于确保制备化合物的纯度，身份和质量，包括CGMP批次的质量保证/QC； （4）根据需要的其他研究，例如溶解度/稳定性。 与基准年增量相同1。