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Expression and Purification of Virus-like Particles for Vaccination
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Influenza A Virus Production Following Quality by Design Principles.

Tilia Zinnecker1, Kristin Thiele2, Timo Schmidberger3

  • 1Max Planck Institute for Dynamics of Complex Technical Systems Magdeburg Germany.

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|April 24, 2025
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Summary

This study applied Quality by Design (QbD) to optimize influenza A virus production using Madin-Darby canine kidney (MDCK) cell lines. The approach identified critical process parameters (CPPs) and established robust manufacturing designs, improving yield and quality.

Keywords:
Ambr 15Design of ExperimentsQuality by Designcell cultureinfluenza A virusprocess development

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Development
  • Vaccine Production

Background:

  • Cell culture-based pharmaceutical manufacturing requires managing numerous parameters impacting yield, efficiency, robustness, and product quality.
  • Quality by Design (QbD) principles offer a strategic framework for process optimization and streamlining regulatory approval for Chemistry, Manufacturing, and Controls (CMC).

Purpose of the Study:

  • To mimic a QbD approach for optimizing an influenza A virus production process.
  • To identify Critical Process Parameters (CPPs) through quantitative risk assessment.
  • To establish robust design spaces for efficient viral vaccine manufacturing.

Main Methods:

  • Utilized two distinct clonal suspension Madin-Darby canine kidney (MDCK) cell lines for influenza A virus production.
  • Conducted a quantitative risk assessment to identify biological and technical CPPs.
  • Employed an Ambr 15 scale-down system with Design of Experiments (DoE) to study CPP effects and interactions.
  • Verified findings at a >100-fold increased working volume.

Main Results:

  • Identified and analyzed four critical process parameters (CPPs) using a Design of Experiments (DoE) approach.
  • Established robust design spaces with <1% risk of failure, indicating improved process reliability.
  • Observed potential for enhanced virus titer and yield, while maintaining low levels of DNA and total protein impurities.

Conclusions:

  • The QbD-mimicking approach successfully optimized influenza A virus production processes.
  • The developed design spaces ensure high process robustness and product quality.
  • This methodology can streamline process development and regulatory approval for viral vaccine manufacturing.