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Device for automated aseptic sampling: Automated sampling solution for future cell and gene manufacturing.

Liu Dan1, Wu Ying Ying1, Akshaya V Prabhu1

  • 1Bioprocessing Technology Institute (BTI), Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.

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Summary
This summary is machine-generated.

Automated aseptic sampling using the Device for Automated Aseptic Sampling (DAAS) minimizes contamination risks and labor in cell manufacturing. This technology enables consistent, accurate cell sampling for improved cell and gene therapy production.

Keywords:
aseptic samplingautomated samplingautomationcell and gene therapycell manufacturingprocess analytical technology

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Area of Science:

  • Biotechnology
  • Cell Manufacturing
  • Process Automation

Background:

  • Manual cell sampling via pipetting is labor-intensive and risks contamination.
  • Current methods can interrupt cell cultures, impacting growth and analysis.
  • Cell and gene therapy manufacturing requires precise and sterile sampling procedures.

Purpose of the Study:

  • To develop an automated, aseptic sampling device for cell and gene therapy manufacturing.
  • To minimize dead volume and contamination risks during cell sampling.
  • To enable accurate, consistent, and less disruptive cell sampling.

Main Methods:

  • Development and testing of the Device for Automated Aseptic Sampling (DAAS).
  • Microbial ingression tests to verify aseptic capabilities.
  • Comparative analysis of cell density and viability against manual pipetting.
  • Demonstration in static flask and automated bioreactor systems with Jurkat and T cells.

Main Results:

  • DAAS verified as an aseptic sampling solution through microbial ingression tests.
  • Achieved comparable cell density and viability to manual sampling with negligible cross-sample carryover.
  • Successfully demonstrated periodic sampling and continuous monitoring over 10 days in BSL-2 conditions.
  • Minimal interruption to cell cultures during automated sampling.

Conclusions:

  • DAAS offers a reliable automated and aseptic solution for cell sampling.
  • Facilitates frequent and less disruptive access to cell samples for manufacturers.
  • Supports enhanced cell culture monitoring, automation, and cost reduction in cell and gene therapy.