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Research ArticleResearch

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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Abstract

Visible particles must be monitored as part of the control strategy for pharmaceutical products. Extraneous (foreign) particles are not acceptable in parenteral drug products. In biopharmaceuticals, formation of protein particles is recognized as an inherent quality attribute. All protein therapeutics contain particles that vary greatly in visibility and size from invisible (sub-micron) to visible (millimeter) and, as part of the control strategy, biopharmaceutical companies are required to monitor and minimize the presence of visible and sub-visible particles in their products. There is an industry-wide unmet need for particle standards for visual inspection of protein therapeutics. A new, semi-quantitative method using particle standards for assessing the levels of small, inherent visible particles is presented. This method can be used during product development to identify a formulation that minimizes particle formation and also during release and stability testing to monitor and control inherent proteinaceous visible particles.

LAY ABSTRACT: Visible particles must be monitored as part of the control strategy for parenteral biopharmaceutical drug products. In these products, formation of protein particles is a natural occurrence. All protein drugs contain particles that vary greatly in visibility and size from invisible (sub-micron) to visible (millimeter), and pharmaceutical companies are required to monitor and minimize the presence of visible and sub-visible particles in their products. There is an industry-wide unmet need for particle standards for visual inspection of protein drugs. A new, semi-quantitative method using particle standards for assessing the levels of small, naturally occurring visible particles is presented. This method can be used during drug development to identify a formulation that minimizes particle formation and also during testing of final clinical or commercial drug product to monitor and control naturally occurring proteinaceous visible particles.

  • Proteins
  • Protein aggregation
  • Protein formulation
  • Stability
  • Biotechnology
  • Visible particles
  • Inherent visible particles
  • Proteinaceous
  • Particle standard
  • Barium sulfate
  • © PDA, Inc. 2016
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PDA Journal of Pharmaceutical Science and Technology: 70 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 2
March/April 2016
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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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