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Efficient high-throughput biological process characterization: Definitive screening design with the ambr250
Mitchell Tai1, Amanda Ly1, Inne Leung1
1Biologics Process Development, Bristol-Myers Squibb, Seattle, WA.
Biotechnology Progress
|July 4, 2015
Summary
High-throughput process characterization using automated mini bioreactors and definitive screening design efficiently models Escherichia coli fermentation for recombinant protein production, aiding quality by design approaches.
Area of Science:
- Biotechnology and bioprocess engineering
- Pharmaceutical process development
- Recombinant protein production
Background:
- Increasing biologic drug pipelines necessitate efficient process development.
- Automated systems like the 250-mL automated mini bioreactor (ambr250™) enhance upstream process development.
- Definitive screening design (DSD) offers an efficient method for factor screening and characterization in process development.
Purpose of the Study:
- To demonstrate a systematic workflow for efficient process characterization.
- To utilize the ambr250™ system and DSD for characterizing an Escherichia coli fermentation process.
- To support quality by design (QbD) strategies in late-stage characterization.
Main Methods:
- Implementation of a 10-factor definitive screening design (DSD) on a 24-bioreactor ambr250™ system.
- Characterization of an Escherichia coli fermentation process for recombinant protein production.
- Validation of the generated process model using laboratory-scale experiments.
Main Results:
- A systematic experimental workflow was established for efficient process characterization.
- The study successfully characterized an E. coli fermentation process using the ambr250™ system and DSD.
- The developed process model was validated, demonstrating its utility for QbD.
Conclusions:
- The combined use of ambr250™ and DSD provides an efficient strategy for bioprocess characterization.
- This approach supports quality by design (QbD) principles for robust control strategies.
- The methodology is valuable for optimizing recombinant protein production processes.
Keywords:
Escherichia coli fermentationambr250definitive screening designdesign of experimenthigh-throughputprocess characterizationprocess developmentquality by designMore Related Videos
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