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Abstract <p>This study describes the generation of monoclonal producer clones using the ClonePix™ FL robotic system. CHO cells producing the enzyme arylsulfatase B (ASB) were used as an example. As a result, 20 leading clones producing the recombinant lysosomal enzyme ASB were selected. The probability of monoclonality calculated using the formula provided by the developers of the ClonePix™ FL system was 99.94%. However, the probability of monoclonality calculated by the Monte Carlo method was 97.79%. The Monte Carlo method provided a more accurate estimate of the probability of monoclonality, allowing us to make adjustments in the process of clone production and optimize cell seeding in a semi-solid medium by taking into account additional parameters. The probability of monoclonality of producer clones is a necessary parameter for drug registration.</p>

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Monte Carlo Method for Calculating the Probability of Monoclonality of Cell Lines

  • 期刊论文

  • 发表日期：

    2025年12月1日

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  • S. S. Timonova,
  • V. I. Pavelko,
  • I. A. Kiric,
  • V. N. Bade,
  • A. A. Piskunov,
  • R. A. Khamitov

摘要

Abstract

This study describes the generation of monoclonal producer clones using the ClonePix™ FL robotic system. CHO cells producing the enzyme arylsulfatase B (ASB) were used as an example. As a result, 20 leading clones producing the recombinant lysosomal enzyme ASB were selected. The probability of monoclonality calculated using the formula provided by the developers of the ClonePix™ FL system was 99.94%. However, the probability of monoclonality calculated by the Monte Carlo method was 97.79%. The Monte Carlo method provided a more accurate estimate of the probability of monoclonality, allowing us to make adjustments in the process of clone production and optimize cell seeding in a semi-solid medium by taking into account additional parameters. The probability of monoclonality of producer clones is a necessary parameter for drug registration.