Wuya College of Innovation, Shenyang Pharmaceutical University, Wenhua Road 103, 110016 Shenyang, China.
CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Company, Ltd, Huanghe Road 226, 050035 Shijiazhuang, China.
Int J Pharm. 2020 Jul 30;585:119441. doi: 10.1016/j.ijpharm.2020.119441. Epub 2020 May 19.
Adopting the Quality by Design (QbD) approach in the drug development process has transformed from "nice-to-do" into a crucial and required part of the development, ensuring the quality of pharmaceutical products throughout their whole life cycles. This review is discussing the implementation of the QbD thinking into the production of long-acting injectable (LAI) PLGA/PLA-based microspheres for the therapeutic peptide and protein drug delivery. Various key elements of the QbD approaches are initially elaborated using Bydureon®, a commercial product of LAI PLGA/PLA-based microspheres, as a classical example. Subsequently, the factors influencing the release patterns and the stability of the peptide and protein drugs are discussed. This is followed by a summary of the state-of-the-art of manufacturing LAI PLGA/PLA-based microspheres and the related critical process parameters (CPPs). Finally, a landscape of generic product development of LAI PLGA/PLA-based microspheres is reviewed including some major challenges in the field.
采用质量源于设计（QbD）方法于药物开发过程已从“锦上添花”转变为开发过程中的关键且必需的部分，确保了整个药物生命周期中药物产品的质量。本文综述了 QbD 理念在长效注射（LAI）PLGA/PLA 基微球生产中的应用，用于治疗性肽和蛋白药物传递。使用 Bydureon®（一种 LAI PLGA/PLA 基微球的商业化产品）作为经典示例，最初详细阐述了 QbD 方法的各个关键要素。随后，讨论了影响肽和蛋白药物释放模式和稳定性的因素。接下来总结了 LAI PLGA/PLA 基微球的制造和相关关键工艺参数（CPPs）的最新技术。最后，综述了 LAI PLGA/PLA 基微球的仿制药开发概况，包括该领域的一些主要挑战。
