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4D Imaging of Protein Aggregation in Live Cells
Published on: April 5, 2013
Protein aggregation and bioprocessing
Mary E M Cromwell1, Eric Hilario, Fred Jacobson
1Early Stage Pharmaceutical Development, Genentech Inc, South San Francisco, CA 94080, USA. cromwell@gene.com
The AAPS Journal
|October 10, 2006
Summary
Protein aggregation during biotherapeutic manufacturing can be controlled by optimizing cell culture and purification processes. Implementing strategies to minimize and remove protein aggregates is crucial for successful production.
Area of Science:
- Biopharmaceutical Manufacturing
- Protein Chemistry
- Process Development
Background:
- Protein aggregation is a significant challenge in biotherapeutic production.
- Uncontrolled aggregation can impact product efficacy and safety.
- Existing methods for aggregate removal are established at manufacturing scale.
Purpose of the Study:
- To highlight strategies for controlling protein aggregation during biomanufacturing.
- To emphasize the importance of process optimization in minimizing aggregate formation.
- To discuss the integration of aggregate removal techniques.
Main Methods:
- Controlling environmental factors during cell culture (e.g., media components).
- Implementing specific strategies to reduce protein aggregation.
- Utilizing established methods for aggregate removal during purification.
- Monitoring protein-equipment compatibility throughout the process.
Main Results:
- Process control during cell culture can influence the amount of aggregate produced.
- Targeted strategies can effectively minimize protein aggregation.
- Scale-up of aggregate removal steps has been demonstrated successfully.
- Careful process development is essential to prevent aggregation.
Conclusions:
- Minimizing protein aggregation requires a multi-faceted approach.
- Controlling the manufacturing environment and purification process is key.
- Proactive process design and monitoring are vital for producing stable biotherapeutics.
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