A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins-Reference-Cited by-同舟云学术

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A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins

Published:2017-08-14 Issue:7 Volume:9 Page:1186-1196
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Xu Weichen¹,Jimenez Rod Brian¹,Mowery Rachel²,Luo Haibin³,Cao Mingyan¹,Agarwal Nitin²,Ramos Irina³,Wang Xiangyang¹,Wang Jihong¹

Affiliation:

1. Analytical Sciences, MedImmune, One MedImmune Way, Gaithersburg, MD USA

2. Cell Culture and Fermentation Sciences, MedImmune, One MedImmune Way, Gaithersburg, MD USA

3. Purification Process Sciences, MedImmune; One MedImmune Way, Gaithersburg, MD USA

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2017.1364326

Reference39 articles.

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

2. Introduction to the application of QbD principles for the development of monoclonal antibodies

3. Implementing quality by design for biotech products: Are regulators on track?

4. Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose

5. High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans

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1. Basic Regulatory Science Behind Drug Substance and Drug Product Specifications of Monoclonal Antibodies and Other Protein Therapeutics;Journal of Pharmaceutical Analysis;2023-12

2. A novel filter-assisted protein precipitation (FAPP) based sample pre-treatment method for LC-MS peptide mapping for biosimilar characterization;Journal of Pharmaceutical and Biomedical Analysis;2023-09

3. Recent applications of quantitative mass spectrometry in biopharmaceutical process development and manufacturing;Journal of Pharmaceutical and Biomedical Analysis;2023-09

4. What is the role of current mass spectrometry in pharmaceutical analysis?;Mass Spectrometry Reviews;2023-07-28

5. Multi-Attribute Method (MAM): An Emerging Analytical Workflow for Biopharmaceutical Characterization, Batch Release and cGMP Purity Testing at the Peptide and Intact Protein Level;Critical Reviews in Analytical Chemistry;2023-07-25

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