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Exploiting mAb structure characteristics for a directed QbD implementation in early process development.

Micael Karlberg1, Moritz von Stosch1, Jarka Glassey1

  • 1a School of Chemical Engineering and Advanced Materials , Newcastle University , Newcastle upon Tyne , UK.

Critical Reviews in Biotechnology
|March 9, 2018
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Summary
This summary is machine-generated.

Quantitative structure-activity relationships (QSAR) enhance monoclonal antibody development by linking protein structure to process performance. This improves early risk assessment and aids quality by design implementation in biopharmaceutical manufacturing.

Keywords:
Quality by designearly process developmentmonoclonal antibodiesproduct understandingquantitative structure-activity relationship

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Area of Science:

  • Biopharmaceutical Development
  • Protein Engineering
  • Process Chemistry

Background:

  • Monoclonal antibody development is lengthy and complex, requiring high product quality for clinical safety.
  • Current quality by design (QbD) frameworks face limitations in risk assessment and understanding process-factor impacts.
  • There is a need for advanced tools for early risk assessment and prediction in bioprocess development.

Purpose of the Study:

  • To explore the application of quantitative structure-activity relationships (QSAR) within the quality by design (QbD) framework.
  • To enhance product understanding by linking monoclonal antibody protein structure to process development.
  • To provide a decision tool for improved risk assessment and process optimization.

Main Methods:

  • Review and detailed explanation of the quantitative structure-activity relationships (QSAR) methodology.
  • Investigation of methods to directly link monoclonal antibody structural properties to process data.
  • Integration of QSAR insights into the existing QbD framework for biopharmaceutical development.

Main Results:

  • QSAR offers a complementary perspective to QbD by revealing how protein structure influences unit operation performance.
  • This approach provides valuable early-stage insights when process understanding is limited.
  • QSAR can significantly enhance risk assessment and decision-making during process development.

Conclusions:

  • Integrating QSAR with QbD can overcome current limitations in implementing quality by design.
  • This combined approach accelerates biopharmaceutical development and reduces costs.
  • QSAR provides a powerful tool for deeper product understanding and process optimization in monoclonal antibody manufacturing.