Native peptide mapping – A simple method to routinely monitor higher order structure changes and relation to functional activity-Reference-Cited by-同舟云学术

Native peptide mapping – A simple method to routinely monitor higher order structure changes and relation to functional activity

Published:2019-10-04 Issue:8 Volume:11 Page:1391-1401
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Degueldre Michel¹^ORCID,Wielant Annemie¹,Girot Eglantine¹,Burkitt Will²,O’Hara John²,Debauve Gaël¹^ORCID,Gervais Annick¹,Jone Carl¹

Affiliation:

1. Department of Analytical Science Biologicals, UCB, Braine L’Alleud, Belgium

2. Department of Analytical Science Biologicals, UCB, Slough, UK

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2019.1634460

Reference60 articles.

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2. ICH Q6B. Specifications: test procedures and acceptance criteria for biotechnological/biological products. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf., 21 January 2019

3. ICH Q7. Good manufacturing practice guide for active pharmaceutical ingredients. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf, 21 January 2019.

4. Determination of critical quality attributes for monoclonal antibodies using quality by design principles

5. Quality by Design: Concept to Applications

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