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AI-Enhanced Continued Process Verification for Ultrafiltration/Diafiltration.

Naveen G Jesubalan1, Nikita Saxena2, Vinesh Balakrishnan Yezhuvath3

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Biotechnology and Bioengineering
|September 30, 2025
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Summary
This summary is machine-generated.

Biopharmaceutical manufacturers can streamline continued process verification (CPV) using a new framework. This approach automates data analysis for ultrafiltration-diafiltration, enhancing process control and quality assurance.

Keywords:
continued process verification (CPV)control chartsmachine learningmonoclonal antibodyultrafiltration diafiltration (UF DF)

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Analytical Technology (PAT)
  • Quality by Design (QbD)

Background:

  • Regulatory bodies like the FDA and EU GMP Annex 15 mandate continuous process control for biopharmaceuticals.
  • Ensuring consistent drug product quality necessitates robust process verification throughout the product lifecycle.
  • Manual data handling in biopharmaceutical manufacturing is inefficient and prone to errors.

Purpose of the Study:

  • To develop a streamlined framework for continued process verification (CPV).
  • To optimize the ultrafiltration-diafiltration unit operation within biopharmaceutical manufacturing.
  • To facilitate the adoption of Industry 4.0 principles in biopharmaceutical production.

Main Methods:

  • Implemented automated data acquisition using sensors.
  • Developed predictive machine learning models for process analysis.
  • Utilized statistical trending against control limits and process capability assessments (Cpk, Ppk).
  • Integrated fault detection and a comprehensive process control strategy.

Main Results:

  • The proposed framework enables efficient CPV for ultrafiltration-diafiltration.
  • The study demonstrates a data-driven approach to process monitoring and control.
  • The methodology supports enhanced process understanding and capability assessment.

Conclusions:

  • The developed framework offers a practical solution for implementing CPV in the biopharmaceutical industry.
  • This approach enhances process control, reduces errors, and ensures product quality.
  • It represents a significant step towards integrating Industry 4.0 in biopharmaceutical manufacturing.