PDA Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals (single user digital version)

Jun 2016
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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.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Reprocessing Considerations
  4. Regulatory Considerations
  5. Appendix I: Hypothetical Case Study — Anion Exchange Chromatography
  6. Appendix II: Case Study — Refiltration
  7. References

Figures and Tables Index