| Autor: |
Martin Pitschke, Kerstin Müller, Mark Jostameling, Andreas Herrmann, Andreas Richter |
| Rok vydání: |
2004 |
| Předmět: |
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| Zdroj: |
Antibodies ISBN: 9781461347019 |
| DOI: |
10.1007/978-1-4419-8875-1_6 |
| Popis: |
The quality control of biopharmaceutical antibodies intended for human use are required to follow guidelines and regulations set down by national and international regulatory authorities. The US Food and Drug Administration (FDA) issued a guidance in 1997 specifically for antibody products in its “Points to consider in the manufacture and testing of monoclonal antibody products for human use”. This guideline describes the quality control for the entire production process from cell line characterisation through to clinical considerations. In this chapter we will focus on analytical techniques for controlling the downstream processing and the release of the bulk material as well as finished product. For additional information on cell line characterisation refer to the relevant guidelines ICH Q5B and ICH Q5D or Fels, 2001. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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