On the Analytical Superiority of 1D NMR for Fingerprinting the Higher Order Structure of Protein Therapeutics Compared to Multidimensional NMR Methods-Reference-Cited by-同舟云学术

On the Analytical Superiority of 1D NMR for Fingerprinting the Higher Order Structure of Protein Therapeutics Compared to Multidimensional NMR Methods

Published:2015-05-14 Issue:11 Volume:87 Page:5539-5545
ISSN:0003-2700
Container-title:Analytical Chemistry
language:en
Short-container-title:Anal. Chem.

Author:

Poppe Leszek¹,Jordan John B.¹,Rogers Gary²,Schnier Paul D.¹

Affiliation:

1. Discovery Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320, United States

2. Product Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320, United States

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.analchem.5b00950

Reference22 articles.

1. International Conference on Harmonisation (IHC) Expert Working GroupComparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; 2004; http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf.

2. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

3. Physicochemical and Biologic Comparability of a Biosimilar Granulocyte Colony-Stimulating Factor with Its Reference Product

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