Biologics Formulation Factors Affecting Metal Leachables from Stainless Steel-Reference-Cited by-同舟云学术

Biologics Formulation Factors Affecting Metal Leachables from Stainless Steel

Published:2011-03 Issue:1 Volume:12 Page:411-421
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Zhou Shuxia,Schöneich Christian,Singh Satish K.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Link

http://link.springer.com/content/pdf/10.1208/s12249-011-9592-3.pdf

Reference31 articles.

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3. Markovic I. Challenges associated with extractables and/or leachables substances in therapeutic biologic protein products. Am Pharm Rev. 2006;9(6):20–7.

4. Bee JS et al. Precipitation of a monoclonal antibody by soluble tungsten. J Pharm Sci. 2009;98(9):3290–301.

5. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ICH). Guideline for industry: impurities in new drug substances, ICH Q3A

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