PDA TR 74

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.