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

生物相似性的标准是对一种生物的分析和功能相似性的证明。 生物相似的产品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平台，允许进行可靠的表征和评估 生物相似药物产品的可比性。执行这些活动时的一个关键挑战是 配方中的赋形剂干扰了典型的分析和功能工具 其他常规用于药物物质的表征和可比性。 因此，生物相似制造商求助于各种方法来分离生物治疗性 药物产品配方中的蛋白质。然而，这带来了一种不确定性 通过这种分离对蛋白质稳定性和功能的影响。我们将首先确定问题的根源 影响生物治疗药物产品特性的挑战。用这个武装起来 理解，这个项目旨在创建一个分析平台，使我们能够可靠地执行 生物相似药物的分析与功能表征及可比性评价 产品。辅料的综合表征，单独和在组合物模拟中 将开展生物相似产品。此外，分析和功能表征 将进行生物仿制药和参考产品的研究。最后，集装箱封闭系统 将会被评估。

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.