Development of Protein-Like Reference Material for Semi-Quantitatively Monitoring Visible Proteinaceous Particles in Biotherapeutics

Srivalli N Telikepalli; Kristen Gonzalez; Sonia Dragulin-Otto; Dean Ripple; Michael J. Carrier; Mariam Khan

doi:10.5731/pdajpst.2018.008953

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Development of Protein-Like Reference Material for Semi-Quantitatively Monitoring Visible Proteinaceous Particles in Biotherapeutics

Srivalli N Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael J. Carrier and Mariam Khan

PDA Journal of Pharmaceutical Science and Technology June 2019, pdajpst.2018.008953; DOI: https://doi.org/10.5731/pdajpst.2018.008953

Srivalli N Telikepalli

1 National Institute of Standards and Technology;

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For correspondence: snt2@nist.gov

Kristen Gonzalez

2 MedImmune

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For correspondence: gonzalezk@medimmune.com

Sonia Dragulin-Otto

2 MedImmune

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For correspondence: dragulin-ottos@medimmune.com

Dean Ripple

1 National Institute of Standards and Technology;

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For correspondence: dean.ripple@nist.gov

Michael J. Carrier

1 National Institute of Standards and Technology;

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For correspondence: michael.carrier@nist.gov

Mariam Khan

2 MedImmune

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For correspondence: khanma@medimmune.com

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pdajpst.2018.008953

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

Received May 10, 2018
Accepted February 27, 2019
Published online June 17, 2019.

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Author Information

Srivalli N Telikepalli1,3 (snt2{at}nist.gov),
Kristen Gonzalez2 (gonzalezk{at}medimmune.com),
Sonia Dragulin-Otto2 (dragulin-ottos{at}medimmune.com),
Dean Ripple1 (dean.ripple{at}nist.gov),
Michael J. Carrier1 (michael.carrier{at}nist.gov) and
Mariam Khan2 (khanma{at}medimmune.com)

¹ National Institute of Standards and Technology;
² MedImmune

↵* Corresponding author; email: snt2{at}nist.gov

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Development of Protein-Like Reference Material for Semi-Quantitatively Monitoring Visible Proteinaceous Particles in Biotherapeutics

Srivalli N Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael J. Carrier, Mariam Khan

PDA Journal of Pharmaceutical Science and Technology Jun 2019, pdajpst.2018.008953; DOI: 10.5731/pdajpst.2018.008953

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Development of Protein-Like Reference Material for Semi-Quantitatively Monitoring Visible Proteinaceous Particles in Biotherapeutics

Srivalli N Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael J. Carrier, Mariam Khan

PDA Journal of Pharmaceutical Science and Technology Jun 2019, pdajpst.2018.008953; DOI: 10.5731/pdajpst.2018.008953

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Keywords

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

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