Process Analytic Technologies (PAT) for Biologics

生物制剂过程分析技术 (PAT)

• 批准号: 8153988
• 负责人: WILLIAM KESSLER
• 金额: $ 19.84万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-24 至 2011-06-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8153988
• 关键词: Engineering; Pharmaceutical Preparations; Pharmacologic Substance; Process; Small Business Innovation Research Grant; Technology

The development of biologic drugs for cancer treatment often requires formulations that must be lyophilized to produce stable drug products. The process of developing a drug formulation and freeze-drying process begins with laboratory experiments followed by scaled-up to pilot and production scale lyophilizers. A major challenge during early formulation and lyophilization process development is the cost and limited supply of active pharmaceutical ingredient available for development and the lack of a representative small scale lyophilizer that emulates a production scale dryer. Current laboratory dryers hold hundreds of vials and their operation and product drying behavior with just a few vials is different than with a full load of vials due to highly atypical radiation heat transfer. The process information gathered drying a few vials in a standard laboratory dryer is relatively useless. The goal of this Phase I SBIR program is to design , fabricate, test, and apply a mini-lyophilizer that dries one to seven product vials under heat and mass transfer conditions typically encountered in larger production freeze dryers. The mini lyophilizer will be outfitted with process analytic technology tools that enable the use of scientific and engineering principles for successful process scale up and economically viable drug product manufacturing.

用于癌症治疗的生物药物的开发通常要求制剂必须冷冻干燥才能产生稳定的药物产品。开发药物配方和冷冻干燥工艺的过程从实验室实验开始，然后扩大到中试和生产规模的冻干剂。早期配方和冻干工艺开发过程中的一个主要挑战是可供开发的有效药物成分的成本和供应有限，以及缺乏具有代表性的小型冻干机来模拟生产规模的干燥机。目前的实验室干燥机容纳数百个瓶子，由于高度非典型的辐射换热，仅用几个瓶子的操作和产品干燥行为与满载瓶子的不同。收集的过程信息在标准的实验室烘干机中烘干几个瓶子相对来说是无用的。该第一阶段SBIR计划的目标是设计、制造、测试和应用一种微型冻干机，该干燥机在大型生产冷冻干燥机中通常会遇到的热量和传质条件下干燥一到七个产品瓶。迷你冷冻干燥器将配备过程分析技术工具，使科学和工程原理能够成功地扩大过程规模，并在经济上可行的药物产品制造。