DEVEL. OF A MINI-LYOPHILIZER FOR PHARMA. PRODUCTFORMUL.& PRO. & DEVEL. HHSN261201

开发。

• 批准号: 8762894
• 负责人: WILLIAM KESSLER
• 金额: $ 99.53万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2015-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8762894
• 关键词: Behavior; Biologic Development; Computer software; Development; Documentation; Drug Formulations; Engineering; Evaluation; Freeze Drying; Freezing; Goals; Heating; Joints; Laboratories; Performance; Pharmaceutical Preparations; Phase; Process; Production; Protein Structure Initiative; Proteins; Radiation; Reporting; Small Business Innovation Research Grant; Specific qualifier value; System; Technology; Temperature; Testing; United States National Institutes of Health; Update; Vacuum Pumps; Vial device; cancer therapy; cost; design; experience; improved; information gathering; microbial alkaline proteinase inhibitor; operation; physical science; pressure; programs; prototype; research study; scale up; sensor; tool

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 scale-up to pilot and production scale lyophilizers. A major challenge during early formulation and lyophilization process development is the cost and limited supply of API available for development and the lack of 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 jsut 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 typicaly encountered in larger production freeze dryers. The mini lyophilizer will be outfitted with process analytical technology tools that enable the use of scientific and engineering principles for successful scale up and economically viable drug product manufacturing.

用于癌症治疗的生物药物的开发通常需要必须冻干以生产稳定药物产品的制剂。开发药物制剂和冷冻干燥工艺的过程始于实验室实验，然后是扩大到中试和生产规模的冻干机。早期制剂和冻干工艺开发期间的主要挑战是可用于开发的API的成本和有限供应以及缺乏模拟生产规模干燥器的代表性小规模冻干机。目前的实验室干燥器容纳数百个小瓶，并且由于高度非典型的辐射热传递，它们的操作和产品干燥行为与只有几个小瓶的情况下不同于满载小瓶的情况。在标准实验室干燥器中干燥几个小瓶所收集的过程信息相对无用。该阶段I SBIR计划的目标是设计、制造、测试和应用小型冻干机，该冻干机在大型生产冻干机通常遇到的传热和传质条件下干燥1至7个产品小瓶。微型冻干机将配备工艺分析技术工具，可使用科学和工程原理成功扩大规模和经济上可行的制剂生产。