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Microfluidic chip-based single-cell cloning to accelerate biologic production timelines.

Jonathan Diep1, Huong Le1, Kim Le1

  • 1Drug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.

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|July 29, 2021
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Summary
This summary is machine-generated.

Accelerating cell line development (CLD) using the Berkeley Lights Beacon Instrument (BLI) for early single-cell cloning (SCC) reduced timelines by up to 30% without compromising clone quality or stability.

Keywords:
Berkeley Lights Instrumentcell line developmentsingle-cell cloningspeed-to-markettimeline

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Area of Science:

  • Biotechnology
  • Biopharmaceutical Manufacturing
  • Cell Line Development

Background:

  • Cell line development (CLD) is a lengthy process involving extensive screening of single-cell clones.
  • Current methods like limiting dilution or FACS for single-cell cloning (SCC) are resource-intensive.
  • Optimizing CLD is crucial for efficient biomanufacturing.

Purpose of the Study:

  • To investigate the use of the Berkeley Lights Beacon Instrument (BLI) for early single-cell cloning (SCC).
  • To assess the impact of accelerated SCC on cell line development timelines.
  • To evaluate the manufacturability and stability of clones derived from accelerated processes.

Main Methods:

  • Application of the BLI for early SCC on transfected pools.
  • Single-cell cloning performed at high viability (>85%) or during selection (<30%).
  • Characterization of clones for growth, productivity, product quality, and long-term stability (50 population doubling levels).

Main Results:

  • Early SCC on the BLI achieved up to a 30% reduction in the overall CLD timeline.
  • Clones from accelerated processes showed comparable growth, productivity, and quality to standard processes.
  • Long-term stability of early-derived clones was equivalent to standard-derived clones.

Conclusions:

  • Early SCC using the BLI is an effective strategy to accelerate CLD timelines.
  • This approach yields high-quality clones suitable for biomanufacturing platforms.
  • Accelerated CLD on the BLI maintains clone manufacturability and stability.