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Research ArticleResearch

Mycoplasma Clearance and Risk Analysis in a Model Bioprocess

Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054
Julie Wang
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Sarah Johnson
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Matthew Brown
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Scott Lute
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Cyrus Agarabi
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Alena Dabrazhynetskaya
2Division of Viral Products/Office of Vaccine Research and Review/Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903
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Vladimir Chizhikov
2Division of Viral Products/Office of Vaccine Research and Review/Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903
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Kurt Brorson
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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  • For correspondence: Kurt.Brorson@fda.hhs.gov
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Abstract

Mycoplasmas are a type of bacteria that lack cell walls and are occasional cell culture contaminants. In a biotechnology setting, because they can pass through 0.2 μm filters, mycoplasmas could pose a potential patient safety hazard if undetected contaminants from the production culture were not completely removed by downstream biotechnology manufacturing. In this study we investigated the ability of typical commercial monoclonal antibody purification operations to clear and kill mycoplasmas, using Acholeplasma laidlawii as a model organism. Our spike/removal studies have shown that protein A column chromatography clears about 4–5 log10. Column regeneration effectively prevents A. laidlawii column carryover between chromatography runs. Moreover, low-pH hold steps, typically implemented after protein A purification, effectively kill A. laidlawii using either pH 3.8 glycine or acetate solutions (LRV ≥5.30 and ≥4.57, respectively). Solvent/detergent treatment, used in some processes instead of low-pH hold, also completely kills highly concentrated A. laidlawii (LRV ≥5.95).

LAY ABSTRACT: Biotechnology medicines need to be free from contaminating microorganisms such as mycoplasmas, a type of bacteria that can cause disease in humans (e.g., walking pneumonia). Here we show that some monoclonal antibody manufacturing steps can effectively clear and/or kill Acholeplasma laidlawii, a model mycoplasma species used in our study. This provides an additional level of safety assurance of biotechnology medicines for patients.

  • Mycoplasma
  • Acholeplasma laidlawii
  • Bioprocessing
  • Protein A chromatography
  • Solvent/detergent
  • Low-pH hold
  • Spike/clearance
  • Cell culture
  • © PDA, Inc. 2017
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PDA Journal of Pharmaceutical Science and Technology: 71 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
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Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 99-114; DOI: 10.5731/pdajpst.2016.007054

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Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 99-114; DOI: 10.5731/pdajpst.2016.007054
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Keywords

  • Mycoplasma
  • Acholeplasma laidlawii
  • Bioprocessing
  • Protein A chromatography
  • Solvent/detergent
  • Low-pH hold
  • Spike/clearance
  • Cell culture

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