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This study introduces an AI-driven robotic lab framework for biologics process development. It significantly improves cell culture efficiency and protein production titers, accelerating biomanufacturing.

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Area of Science:

  • Biotechnology
  • Process Engineering
  • Artificial Intelligence

Background:

  • Traditional biologics process development is inefficient, relying on labor-intensive optimization.
  • Current methods for antibody and recombinant protein production require extensive iterative cell culture optimization.

Purpose of the Study:

  • To develop an autonomous laboratory framework, the Industrial Smart Lab Framework for Cell Culture (ISLFCC), to enhance cell culture processes.
  • To accelerate biologics development and biomanufacturing through AI and robotic automation.

Main Methods:

  • Implemented ISLFCC, combining deep learning (decoder-only transformer models) with robotic experimentation.
  • Utilized an IoT system for data transmission from bioreactors to AI models and execution of automated actions.
  • Employed AI to predict cell states and recommend optimal actions like nutrient feed and temperature adjustments.

Main Results:

  • Achieved an average titer increase of 26.8% for three cell clones in a single batch.
  • Maintained lactate levels below 1 g/L without late-phase rebound.
  • Demonstrated enhanced reproducibility, data accuracy, adaptability, and scalability in 3 and 15 L bioreactors.

Conclusions:

  • The ISLFCC framework offers a transformative, autonomous, and data-driven approach to biomanufacturing.
  • This AI-driven methodology significantly accelerates biologics development compared to traditional empirical methods.
  • Represents a paradigm shift towards automated, high-throughput cell culture in biopharmaceutical production.