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Research ArticleResearch

A Spectral Method for Color Quantitation of a Protein Drug Solution

Trevor E. Swartz, Jian Yin, Thomas W. Patapoff, Travis Horst, Susan M. Skieresz, Gordon Leggett, Charles J. Morgan, Kimia Rahimi, Joseph Marhoul and Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 361-381; DOI: https://doi.org/10.5731/pdajpst.2016.006486
Trevor E. Swartz
1Early Stage Pharmaceutical Development Department,
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  • For correspondence: swartz.trevor@gene.com
Jian Yin
1Early Stage Pharmaceutical Development Department,
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Thomas W. Patapoff
1Early Stage Pharmaceutical Development Department,
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Travis Horst
1Early Stage Pharmaceutical Development Department,
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Susan M. Skieresz
2Protein Analytical Chemistry,
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Gordon Leggett
5HunterLab Inc., Reston, VA
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Charles J. Morgan
4Pharma Technical Regulatory, Genentech Inc., South San Francisco, CA; and
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Kimia Rahimi
2Protein Analytical Chemistry,
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Joseph Marhoul
3Biostatistics Group,
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Bruce Kabakoff
1Early Stage Pharmaceutical Development Department,
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Abstract

Color is an important quality attribute for biotherapeutics. In the biotechnology industry, a visual method is most commonly utilized for color characterization of liquid drug protein solutions. The color testing method is used for both batch release and on stability testing for quality control. Using that method, an analyst visually determines the color of the sample by choosing the closest matching European Pharmacopeia reference color solution. The requirement to judge the best match makes it a subjective method. Furthermore, the visual method does not capture data on hue or chroma that would allow for improved product characterization and the ability to detect subtle differences between samples. To overcome these challenges, we describe a quantitative method for color determination that greatly reduces the variability in measuring color and allows for a more precise understanding of color differences. Following color industry standards established by International Commission on Illumination, this method converts a protein solution's visible absorption spectra to L*a*b* color space. Color matching is achieved within the L*a*b* color space, a practice that is already widely used in other industries. The work performed here is to facilitate the adoption and transition for the traditional visual assessment method to a quantitative spectral method. We describe here the algorithm used such that the quantitative spectral method correlates with the currently used visual method. In addition, we provide the L*a*b* values for the European Pharmacopeia reference color solutions required for the quantitative method. We have determined these L*a*b* values by gravimetrically preparing and measuring multiple lots of the reference color solutions. We demonstrate that the visual assessment and the quantitative spectral method are comparable using both low- and high-concentration antibody solutions and solutions with varying turbidity.

LAY ABSTRACT: In the biotechnology industry, a visual assessment is the most commonly used method for color characterization, batch release, and stability testing of liquid protein drug solutions. Using this method, an analyst visually determines the color of the sample by choosing the closest match to a standard color series. This visual method can be subjective because it requires an analyst to make a judgment of the best match of color of the sample to the standard color series, and it does not capture data on hue and chroma that would allow for improved product characterization and the ability to detect subtle differences between samples. To overcome these challenges, we developed a quantitative spectral method for color determination that greatly reduces the variability in measuring color and allows for a more precise understanding of color differences. The details of the spectral quantitative method are described. A comparison between the visual assessment method and spectral quantitative method is presented. This study supports the transition to a quantitative spectral method from the visual assessment method for quality testing of protein solutions.

  • Therapeutic protein solutions
  • Color measurement
  • Visual color assessment
  • Quantitative color assessment
  • © PDA, Inc. 2016
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PDA Journal of Pharmaceutical Science and Technology: 70 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 4
July/August 2016
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A Spectral Method for Color Quantitation of a Protein Drug Solution
Trevor E. Swartz, Jian Yin, Thomas W. Patapoff, Travis Horst, Susan M. Skieresz, Gordon Leggett, Charles J. Morgan, Kimia Rahimi, Joseph Marhoul, Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 361-381; DOI: 10.5731/pdajpst.2016.006486
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Keywords

  • Therapeutic protein solutions
  • color measurement
  • visual color assessment
  • quantitative color assessment

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A Spectral Method for Color Quantitation of a Protein Drug Solution
Trevor E. Swartz, Jian Yin, Thomas W. Patapoff, Travis Horst, Susan M. Skieresz, Gordon Leggett, Charles J. Morgan, Kimia Rahimi, Joseph Marhoul, Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 361-381; DOI: 10.5731/pdajpst.2016.006486

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