Correlated analytical and functional evaluation of higher order structure perturbations from oxidation of NISTmAb-Reference-Cited by-同舟云学术

Correlated analytical and functional evaluation of higher order structure perturbations from oxidation of NISTmAb

Published:2023-01-22 Issue:1 Volume:15 Page:
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Solomon Tsega L.¹,Delaglio Frank¹,Giddens John P.¹,Marino John P.¹,Yu Yihua Bruce²,Taraban Marc B.²,Brinson Robert G.¹^ORCID

Affiliation:

1. Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology and the University of Maryland, Rockville, Maryland, United States

2. Bio- and Nano-Technology Center, University of Maryland School of Pharmacy, and Institute for Bioscience and Biotechnology Research, Rockville, Maryland, United States

Funder

NIST Biomanufacturing Program and NIST for support of biomolecular NMR instrumentation

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2022.2160227

Reference51 articles.

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4. Guideline for Industry Quality of biotechnological products: stability testing of biotechnological/biological products. Silver spring (MD): United States Food and Drug Administration; 1996. p. 10.

5. Draft Guidance for Industry Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.Silver Spring (MD): United States Food and Drug Administration; 2019. p. 28.

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