$162
PDA TR 74
2016
Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals
- Format:
- Language(s) :
- Published :
- English
- 06/01/2016
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.
| PDA TR 74 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | PDA TR 74 |
| Scope | Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals |
| Publisher | PDA - Parenteral Drug Association |
| Languages | English |
| State | |
| Publication Year | 2016 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 480 KB |
| ISBN(s) | 9780939459889 |
| Number of Pages | 33 |
| Product Code(s) | 01074 |
| Published | 06/01/2016 |
| PDA TR 74 | ||
|---|---|---|
| History | Publisher Year | |
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