SYNTHESIS OF NON-GMP SMALL MOLECULES Base Year Increment 1

非 GMP 小分子的合成 基准年增量 1

• 批准号: 10788101
• 负责人: JAMES TALTON
• 金额: $ 30.5万
• 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/10788101
• 关键词: Chemicals; Clinical Trials; Contractor; Contracts; Cyclic GMP; Development; Ensure; Equipment; Formulation; Funding; Human Resources; Kilogram; Laboratories; Pharmaceutical Preparations; Pharmaceutical Resources; Pharmacology and Toxicology; Procedures; Process; Reproducibility; Retinoblastoma Protein; Services; Solubility; Work; base; manufacture; small molecule

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.

药物资源分支（NCI/DCTD/DTP/PRB）需要一个承包商，该承包商将提供在cGMP条件下进行工艺开发和散装物料合成所需的服务、人员、设备和设施。待合成的给定材料的量可以在从几克到几千克的范围内。这些材料需要通过明确定义和验证的化学工艺生产，具有高纯度，并具有良好的特性。其预期用于制剂开发、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化为稳健和可重现的大规模工艺;（2）根据需要以数克至数公斤规模合成散装化学品/药物;（3）分析以确保制备的化合物的纯度、身份和质量，包括cGMP批次的QA/QC;和（4）额外的研究，如所需的溶解度/稳定性。