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

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 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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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.

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previous version (June 17, 2019 - 04:45).
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Author Information

Srivalli Telikepalli1,*,
Kristen Gonzalez2,
Sonia Dragulin-Otto2,
Dean Ripple1,
Michael Carrier1 and
Mariam Khan3

¹Biomolecular Measurement Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD;
²Dosage Form Design and Development, AstraZeneca, Gaithersburg, MD; and
³Analytical Sciences, AstraZeneca, Gaithersburg, MD

↵* Corresponding Author: Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD; E-mail: srivalli.telikepalli{at}nist.gov

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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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