Quality attributes of recombinant therapeutic proteins: An assessment of impact on safety and efficacy as part of a quality by design development approach

Author:

Eon-Duval Alex,Broly Hervé,Gleixner Ralf

Publisher

Wiley

Subject

Biotechnology

Reference216 articles.

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8(R2). ICH 2009 http://www.ich.org/

2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Quality Risk Management Q9. ICH 2005 http://www.ich.org/

3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Pharmaceutical Quality Systems (Q10). ICH 2008 http://www.ich.org/

4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Draft Consensus Guideline. ICH Harmonised Tripartite Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). ICH 2011 http://www.ich.org/

5. Considerations for Biotechnology Product Quality by Design

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