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.

生物仿制品的标准是表明A的分析和功能相似性 参考产品的生物仿制产品，没有临床意义的差异 二。我们的目标是开发一个允许可靠表征和评估的平台 生物仿制药的可比性。执行这些活动时的关键挑战是 配方中的赋形剂会干扰典型的分析和功能工具集 否则通常用于药物的表征和可比性。 结果，生物仿制药制造商诉诸于分离生物治疗的各种方法 药物制剂中的蛋白质。但是，这引起了不确定性 通过这种隔离对蛋白质稳定性和功能的影响。我们将首先确定 影响生物治疗药品表征的挑战。用这个 理解，该项目旨在创建一个分析平台，使我们能够执行可靠 生物仿制药的可比性的分析和功能表征和评估 产品。赋形剂的全面表征，单独和模拟组成中 将进行生物仿制产品。另外，分析和功能表征 将进行生物仿制药和参考产品。最后，容器关闭系统 将进行评估。