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Biotherapeutics Evaluation Using Artificial Intelligence Assisted Image Analysis

Published online by Cambridge University Press:  22 July 2022

Charudharshini Srinivasan ,
Christopher Calderon ,
Youlong Ma ,
Dean Ripple ,
Muhammad Ashraf  and
Thomas O'Connor
Charudharshini Srinivasan*
Affiliation:
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA
Christopher Calderon*
Affiliation:
Ursa Analytics and University of Colorado Boulder
Youlong Ma
Affiliation:
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA
Dean Ripple
Affiliation:
National Institute of Standards and Technology (NIST)
Muhammad Ashraf
Affiliation:
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA
Thomas O'Connor
Affiliation:
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA
*
*Corresponding authors: Charudharshini.Srinivasan@fda.hhs.gov, Chris.Calderon@UrsaAnalytics.com
*Corresponding authors: Charudharshini.Srinivasan@fda.hhs.gov, Chris.Calderon@UrsaAnalytics.com

Abstract

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Type
On Demand - Artificial Intelligence, Instrument Automation, and High-Dimensional Data Analytics for Microscopy and Microanalysis
Information
Microscopy and Microanalysis , Volume 28 , Supplement S1 , August 2022 , pp. 3150 - 3152
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Copyright
Copyright © Microscopy Society of America 2022

References

USFDA. Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products. 2014.Google Scholar
Calderon, C. P., et al. J Pharm Sci 107 (2018), p. 999-1008.10.1016/j.xphs.2017.12.008CrossRefGoogle Scholar
Calderon, C. P., et al. Pharmaceutical Research (2022), p. 1-17.Google Scholar
Ripple, D. C., et al. NIST Special Publication (2019), 260-193.Google Scholar
Disclaimer: This article reflects the views of the author and should not be construed to represent FDA's views or policies.Google Scholar