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Research ArticleResearch

Bioprocess: Robustness with Respect to Mycoplasma Species

Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Talia Faison
Division 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.
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Julie Wang
Division 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.
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Sarah Johnson
Division 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.
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Matthew Brown
Division 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.
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Meng-Jung Chiang
Division 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.
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Sherri Dolan
Division 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.
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Carl Breuning
Division 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.
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Sai Rashmika Velugula-Yellela
Division 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.
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Scott Lute
Division 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.
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Erica J. Fratz-Berilla
Division 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.
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  • For correspondence: Erica.berilla@fda.hhs.gov
Kurt Brorson
Division 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.
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PDA Journal of Pharmaceutical Science and Technology: 74 (2)
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Bioprocess: Robustness with Respect to Mycoplasma Species
Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 201-212; DOI: 10.5731/pdajpst.2018.009613

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Bioprocess: Robustness with Respect to Mycoplasma Species
Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 201-212; DOI: 10.5731/pdajpst.2018.009613
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Keywords

  • Mycoplasma
  • Acholeplasma laidlawii
  • Mycoplasma arginini
  • Mycoplasma orale
  • Bioprocessing
  • Protein A chromatography
  • Chromatography column/media
  • Solvent/detergent
  • Low-pH hold
  • Spike/clearance
  • Cell culture
  • Viral filter
  • Media filter
  • Ultraviolet-C irradiation

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