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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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    Japanese Pharmacopeia. Insoluble Particulate Matter Test for Injections. In Japanese Pharmacopeia; The Ministry of Health, Labor and Welfare Ministerial Notification No. 285, 15, 6.07, 2007.
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    United States Pharmacopeia. <788> Particulate Matter in Injections, <789> Particulate Matter in Ophthalmic Solutions, and <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions. In The United States Pharmacopeia–National Formulary; USP 34 NF 29, 2011.
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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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