The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability-Reference-Cited by-同舟云学术

The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability

Published:2018-02-07 Issue:8 Volume:410 Page:2127-2139
ISSN:1618-2642
Container-title:Analytical and Bioanalytical Chemistry
language:en
Short-container-title:Anal Bioanal Chem

Author:

Schiel John E.,Turner Abby,Mouchahoir Trina,Yandrofski Katharina,Telikepalli Srivalli,King Jason,DeRose Paul,Ripple Dean,Phinney Karen

Publisher

Springer Science and Business Media LLC

Subject

Biochemistry,Analytical Chemistry

Link

http://link.springer.com/article/10.1007/s00216-017-0800-1/fulltext.html

Reference20 articles.

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2. International Counsil for Harmonisation. Q6B: Specifications: test procedures and acceptance criteria for biotechnological products. ICH Harmonised Tripartite Guideline; 1999. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf .

3. Arbogast LW, Brinson RG, Formolo T, Hoopes JT, Marino JP. 2D (1)H(N), (15)N correlated NMR methods at natural abundance for obtaining structural maps and statistical comparability of monoclonal antibodies. Pharm Res. 2016;33:462–75. https://doi.org/10.1007/s11095-015-1802-3 .

4. Arbogast LW, Brinson RG, Marino JP. Mapping monoclonal antibody structure by 2D 13C NMR at natural abundance. Anal Chem. 2015;87:3556–61. https://doi.org/10.1021/ac504804m .

5. Arbogast LW, Brinson RG, Marino JP. Application of natural isotopic abundance (1)H-(1)(3)C- and (1)H-(1)(5)N-correlated two-dimensional NMR for evaluation of the structure of protein therapeutics. Methods Enzymol. 2016;566:3–34. https://doi.org/10.1016/bs.mie.2015.09.037 .

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