Platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulations

用于可靠表征和评估冻干和液体制剂中生物仿制药产品的可比性的平台

• 批准号: 10619335
• 负责人: Raj Suryanarayanan
• 金额: $ 197.67万
• 依托单位: NATIONAL INSTITUTE FOR PHARM TECH/EDUC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10619335
• 关键词: Platform; reliable; characterization; evaluation; comparability

The standard for biosimilarity is the demonstration of analytical and functional similarity of a biosimilar product to the reference product, with no clinically meaningful differences between the two. Our objective is to develop a platform that allows for reliable characterization and evaluation of comparability of biosimilar drug products. A key challenge when performing these activities is that the excipients in the formulation interfere with the typical set of analytical and functional tools that are otherwise routinely used for the characterization and comparability of drug substances. As a result, biosimilar manufacturers resort to a variety of approaches to isolate the biotherapeutic protein from the drug product formulation. However, this introduces an uncertainty brought about by the impact of this isolation on protein stability and function. We will first identify the root of challenges that impact the characterization of biotherapeutic drug products. Armed with this understanding, this project aims at creating an analytical platform that allows us to perform reliable analytical and functional characterization and evaluation of the comparability of biosimilar drug products. Comprehensive characterization of excipients, alone and in compositions simulating biosimilar products will be carried out. In addition, analytical and functional characterization of biosimilars and the reference product will be conducted. Finally, the container-closure systems will be evaluated.

生物相似性的标准是证明a的分析和功能相似性