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PDA’s newly released Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals provides guidance in the design, development, controls, procedures, validation, regulatory submission and implementation of reprocessing procedures for biopharmaceutical manufacturing.

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PDA’s newly released Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals 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.

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.

The guidance provided in this report is not intended to establish mandatory standards, but rather to serve as a single-source overview that complements existing guidance documents listed in the reference section.

As a non-member of PDA, you can purchase this trending document for $325. Or, you can join PDA by July 17, 2016 for only $259 and download your personal digital copy for FREE! And, when you become a PDA member, you will gain on-demand access to view the entire online library of more than 65 peer-reviewed Technical Reports – valued at more than $10,000.

This is an opportunity you can’t afford to pass up – join PDA for less than the non-member price of a single Technical Report and gain access to all Technical Reports as well as a wealth of other members-only benefits! Be sure to join by July 17, 2016 to gain FREE access to Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals!

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