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Research ArticleResearch

Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals

Srivalli Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael Carrier and Mariam Khan
PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 418-432; DOI: https://doi.org/10.5731/pdajpst.2018.008953
Srivalli Telikepalli
1Biomolecular Measurement Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD;
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  • For correspondence: srivalli.telikepalli@nist.gov
Kristen Gonzalez
2Dosage Form Design and Development, AstraZeneca, Gaithersburg, MD; and
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Sonia Dragulin-Otto
2Dosage Form Design and Development, AstraZeneca, Gaithersburg, MD; and
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Dean Ripple
1Biomolecular Measurement Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD;
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Michael Carrier
1Biomolecular Measurement Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD;
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Mariam Khan
3Analytical Sciences, AstraZeneca, Gaithersburg, MD
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Article Information

vol. 73 no. 5 418-432
DOI 
https://doi.org/10.5731/pdajpst.2018.008953
PubMed 
31209163

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 9, 2019.

Article Versions

  • previous version (June 17, 2019 - 04:45).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Srivalli Telikepalli1,*,
  2. Kristen Gonzalez2,
  3. Sonia Dragulin-Otto2,
  4. Dean Ripple1,
  5. Michael Carrier1 and
  6. Mariam Khan3
  1. 1Biomolecular Measurement Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD;
  2. 2Dosage Form Design and Development, AstraZeneca, Gaithersburg, MD; and
  3. 3Analytical Sciences, AstraZeneca, Gaithersburg, MD
  1. ↵* Corresponding Author: Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD; E-mail: srivalli.telikepalli{at}nist.gov
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PDA Journal of Pharmaceutical Science and Technology: 73 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 5
September/October 2019
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Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals
Srivalli Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael Carrier, Mariam Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 418-432; DOI: 10.5731/pdajpst.2018.008953

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Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals
Srivalli Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael Carrier, Mariam Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 418-432; DOI: 10.5731/pdajpst.2018.008953
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Keywords

  • Proteins
  • protein aggregation
  • Proteinaceous visible particles
  • Protein particle standard
  • Ethylene tetrafluoroethylene
  • stability

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