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某种物质的分析和功能相似性 生物仿制药与参考产品之间没有临床意义的差异 二。我们的目标是开发一个能够进行可靠表征和评估的平台 生物仿制药产品的可比性。执行这些活动时的一个关键挑战是 配方中的赋形剂会干扰典型的分析和功能工具集 通常用于药物物质的表征和比较。 因此，生物仿制药制造商采取各种方法来分离生物治疗药物 来自药品配方的蛋白质。然而，这带来了一个不确定性 通过这种分离对蛋白质稳定性和功能的影响。我们首先要找出根 影响生物治疗药物产品表征的挑战。有了这个武装 据了解，该项目旨在创建一个分析平台，使我们能够执行可靠的操作 生物仿制药的分析和功能表征以及可比性评估 产品。单独和模拟组合物中赋形剂的综合表征 将开展生物仿制药产品的开发。此外，分析和功能表征 将进行生物仿制药和参考产品。最后，容器封闭系统 将被评估。