Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions

Jian Yin; Trevor E. Swartz; Jian Zhang; Thomas W. Patapoff; Bartolo Chen; Joseph Marhoul; Norman Shih; Bruce Kabakoff; Kimia Rahimi

doi:10.5731/pdajpst.2016.006494

Research ArticleTechnology/Application

Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions

Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff and Kimia Rahimi

PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 382-391; DOI: https://doi.org/10.5731/pdajpst.2016.006494

Jian Yin

1Early Stage Pharmaceutical Development Department,

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For correspondence: Yin.Jian@gene.com

Trevor E. Swartz

1Early Stage Pharmaceutical Development Department,

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Jian Zhang

2Analytical Development and Quality Control Department, and

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Thomas W. Patapoff

1Early Stage Pharmaceutical Development Department,

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Bartolo Chen

2Analytical Development and Quality Control Department, and

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Joseph Marhoul

3Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA

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Norman Shih

1Early Stage Pharmaceutical Development Department,

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Bruce Kabakoff

1Early Stage Pharmaceutical Development Department,

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Kimia Rahimi

2Analytical Development and Quality Control Department, and

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vol. 70 no. 4 382-391

DOI

https://doi.org/10.5731/pdajpst.2016.006494

PubMed

27091890

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online July 18, 2016.

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previous version (April 18, 2016 - 18:05).
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Author Information

Jian Yin1,*,
Trevor E. Swartz1,
Jian Zhang2,
Thomas W. Patapoff1,
Bartolo Chen2,
Joseph Marhoul3,
Norman Shih1,
Bruce Kabakoff1 and
Kimia Rahimi2

¹Early Stage Pharmaceutical Development Department,
²Analytical Development and Quality Control Department, and
³Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA

↵* Corresponding Author: Jian Yin, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080; Telephone: (650) 225-2163; e-mail: Yin.Jian{at}gene.com

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Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions

Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff, Kimia Rahimi

PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 382-391; DOI: 10.5731/pdajpst.2016.006494

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Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions

Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff, Kimia Rahimi

PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 382-391; DOI: 10.5731/pdajpst.2016.006494

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A Spectral Method for Color Quantitation of a Protein Drug Solution

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Keywords

spectral method
color
CIE L*a*b* values
suitability
Precision
Accuracy
Repeatability

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