本技术报告为生物制药制造的再加工程序的设计、开发、控制、程序、验证、监管提交和实施提供指导。它专注于重组生物制药产品，包括通过重组和非重组细胞培养表达系统产生的蛋白质和多肽。在本文件中，将介绍两个案例研究，以说明如何应用一般原则。第一个案例研究提供了数据- 产品/工艺知识、历史和理解的深度和数量如何影响再加工方法，包括监管策略。第二个案例研究与再过滤有关，这是制造业中更常见的情况。

This technical report provides guidance in the design, development, controls, procedures, validation, regulatory submission and implementation of reprocessing procedures for biopharmaceutical manufacturing. It focuses on recombinant biopharmaceutical products, including proteins and polypeptides produced via recombinant and non-recombinant cell-culture expression systems. In this document, two case studies are presented to illustrate how the general principles may be applied. The first case study provides a data-driven illustration of how the depth and quantity of product/process knowledge, history and understanding influences the reprocessing approach, including the regulatory strategy. The second case study is related to refiltration, a more common scenario in manufacturing.