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Mechanistic modeling based process analytical technology implementation for pooling in hydrophobic interaction

Lalita Kanwar Shekhawat1, Anurag S Rathore1

  • 1Dept. of Chemical Engineering, Indian Inst. of Technology, Hauz Khas, New Delhi, India.

Biotechnology Progress
|November 29, 2018
PubMed
Summary
This summary is machine-generated.

A mechanistic model for hydrophobic interaction chromatography (HIC) was used as a process analytical technology (PAT) tool. This approach improved monoclonal antibody purification by enabling robust pooling decisions and consistent aggregate clearance.

Keywords:
hydrophobic interaction chromatographymechanistic modelingmonoclonal antibodiesprocess analytical technologyquality by design

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Area of Science:

  • Biotechnology
  • Chemical Engineering
  • Process Analytical Technology

Background:

  • Batch-to-batch variability in therapeutic protein purification poses a significant challenge.
  • Impurity levels and feed concentration fluctuations impact process robustness.

Purpose of the Study:

  • To apply a mechanistic model of hydrophobic interaction chromatography (HIC) as a process analytical technology (PAT) tool.
  • To enable robust pooling decisions for monoclonal antibody (mAb) aggregate clearance.
  • To improve process control and robustness against feed variations.

Main Methods:

  • Developed and applied a mechanistic model for HIC.
  • Utilized model predictions for feedforward control of pooling decisions.
  • Demonstrated the approach with four different feed batches varying in aggregate levels and concentration.

Main Results:

  • Consistently achieved product with 1.32 ± 0.03% aggregate, meeting the target of <1.5%.
  • The mechanistic model-based PAT approach yielded product purity of 98.68 ± 0.03%.
  • Demonstrated successful aggregate clearance across diverse feed conditions.

Conclusions:

  • Mechanistic modeling of HIC can serve as an effective PAT tool for robust purification processes.
  • Feedforward control using mechanistic models enhances process consistency and product quality.
  • This approach offers comparable or improved purity over traditional column fractionation methods.