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

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.1ORCID

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

Reference51 articles.

1. Molecular and functional analysis of monoclonal antibodies in support of biologics development

2. Quality attributes of recombinant therapeutic proteins: An assessment of impact on safety and efficacy as part of a quality by design development approach

3. Technical Decision Making With Higher Order Structure Data: Perspectives on Higher Order Structure Characterization From the Biopharmaceutical Industry

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 Draft Guidance for Industry Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.Silver Spring (MD):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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