Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products

Patricia W. Cash; Roja Narwal; Sophia V. Levitskaya; Stephan Krause; Derek Murphy; Maryam Mazaheri

doi:10.5731/pdajpst.2015.006064

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Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products

Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy and Maryam Mazaheri

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 134-142; DOI: https://doi.org/10.5731/pdajpst.2015.006064

Patricia W. Cash

1Analytical Biotechnology, MedImmune, Gaithersburg, MD;

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For correspondence: cashp@medimmune.com

Roja Narwal

2Formulation Sciences, MedImmune, Gaithersburg, MD; and

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Sophia V. Levitskaya

1Analytical Biotechnology, MedImmune, Gaithersburg, MD;

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Stephan Krause

1Analytical Biotechnology, MedImmune, Gaithersburg, MD;

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Derek Murphy

3Quality Assurance, MedImmune, Granta Park Cambridge, UK

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Maryam Mazaheri

1Analytical Biotechnology, MedImmune, Gaithersburg, MD;

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vol. 70 no. 2 134-142

DOI

https://doi.org/10.5731/pdajpst.2015.006064

PubMed

26797974

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online April 13, 2016.

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previous version (January 21, 2016 - 17:53).
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Author Information

Patricia W. Cash1,*,
Roja Narwal2,
Sophia V. Levitskaya1,
Stephan Krause1,
Derek Murphy3 and
Maryam Mazaheri1

¹Analytical Biotechnology, MedImmune, Gaithersburg, MD;
²Formulation Sciences, MedImmune, Gaithersburg, MD; and
³Quality Assurance, MedImmune, Granta Park Cambridge, UK

↵* Corresponding Author: E-mail: cashp{at}medimmune.com, Telephone 301-398-4960.

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Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products

Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy, Maryam Mazaheri

PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 134-142; DOI: 10.5731/pdajpst.2015.006064

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Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products

Patricia W. Cash, Roja Narwal, Sophia V. Levitskaya, Stephan Krause, Derek Murphy, Maryam Mazaheri

PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 134-142; DOI: 10.5731/pdajpst.2015.006064

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Keywords

Proteins
protein aggregation
Protein formulation
stability
Biotechnology
Visible particles
inherent visible particles
proteinaceous
Particle standard
barium sulfate

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