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Optimized PCR-based Detection of Mycoplasma
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Mycoplasma Clearance and Risk Analysis in a Model Bioprocess

Julie Wang1, Sarah Johnson1, Matthew Brown1

  • 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.

PDA Journal of Pharmaceutical Science and Technology
|January 17, 2017
PubMed

Insights

Mycoplasmas, cell wall-deficient bacteria, can contaminate biotechnology products. This study demonstrates that monoclonal antibody purification steps effectively remove and inactivate these contaminants, ensuring patient safety.

Area of Science:

  • Biotechnology
  • Microbiology
  • Pharmaceutical Manufacturing

Background:

  • Mycoplasmas are cell wall-deficient bacteria that can contaminate cell cultures.
  • Their small size allows passage through 0.2 μm filters, posing a patient safety risk in biotechnology manufacturing.
  • Undetected mycoplasma contamination can compromise the safety and efficacy of biopharmaceuticals.

Purpose of the Study:

  • To evaluate the efficacy of standard monoclonal antibody (mAb) purification processes in clearing and inactivating mycoplasmas.
  • To assess the removal and killing capabilities of protein A chromatography, low-pH holds, and solvent/detergent treatments.
  • To ensure the safety of biotechnology-derived medicines by addressing potential mycoplasma contamination.

Main Methods:

  • Spike/removal studies using *Acholeplasma laidlawii* as a model mycoplasma.
  • Evaluation of protein A column chromatography for mycoplasma clearance.
  • Assessment of low-pH hold steps (glycine and acetate buffers) for mycoplasma inactivation.
  • Analysis of solvent/detergent treatment for mycoplasma killing efficacy.

Main Results:

  • Protein A chromatography achieved significant mycoplasma clearance (4-5 log10 reduction).
  • Column regeneration effectively prevented mycoplasma carryover between runs.
  • Low-pH hold steps inactivated *A. laidlawii* (LRV ≥4.57), and solvent/detergent treatment achieved complete inactivation (LRV ≥5.95).

Conclusions:

  • Typical monoclonal antibody purification operations effectively clear and inactivate mycoplasmas.
  • These manufacturing steps provide critical control points for ensuring the microbiological safety of biopharmaceuticals.
  • The findings enhance confidence in the safety assurance of biotechnology medicines for patients.
Keywords:
Acholeplasma laidlawiiBioprocessingCell cultureLow-pH holdMycoplasmaProtein A chromatographySolvent/detergentSpike/clearance

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