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A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
Published on: September 22, 2011
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Reshaping cell line development and CMC strategy for fast responses to pandemic outbreak
Zheng Zhang1, Ji Chen1, Junghao Wang1
1Waigaoqiao Free Trade Zone, WuXi Biologics, Shanghai, China.
Biotechnology Progress
|June 20, 2021
Summary
This study presents an accelerated workflow for biologic drug development, optimizing chemistry, manufacturing, and controls (CMC) to expedite clinical trial material supply. It focuses on efficient cell line selection and Good Manufacturing Practices (GMP) compliance for faster therapeutic biologics production.
Area of Science:
- Biopharmaceutical Development
- Vaccine Technology
- Immunology
Background:
- The COVID-19 pandemic necessitated rapid development of vaccines and therapeutic biologics.
- Therapeutic biologics, primarily human IgG antibodies, are often identified using next-generation sequencing (NGS) from convalescent patients.
- Optimizing biologics development timelines is crucial for combating global health crises.
Purpose of the Study:
- To elucidate an accelerated chemistry, manufacturing, and controls (CMC) workflow for biologics development.
- To enable faster supply of Good Manufacturing Practices (GMP) materials for clinical trials.
- To reshape CMC strategies for pandemic preparedness.
Main Methods:
- Utilizing GMP-compliant pool materials for early-phase clinical trials.
- Implementing advanced transfection and cell line selection strategies for enhanced productivity.
- Leveraging next-generation sequencing (NGS) for accelerated cell bank testing.
Main Results:
- An optimized CMC workflow was established for accelerated biologics production.
- Successful use of GMP-compliant pool materials for phase I clinical trials.
- Selection of final clones with consistent product quality for late-stage development.
Conclusions:
- The proposed accelerated CMC workflow significantly reduces the time to supply GMP materials for clinical trials.
- This strategy supports efficient and rapid development of therapeutic biologics during global health emergencies.
- Continuous improvement in transfection, cell line selection, and NGS contributes to faster biomanufacturing.
