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A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
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Improving Downstream Process Related Manufacturability Based on Protein Engineering-A Feasibility Study.

Florian Capito1, Ting Hin Wong1,2, Christine Faust3

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Engineering in Life Sciences
|September 5, 2024
PubMed
Summary

Adapting the surface charge of biotherapeutic proteins improves manufacturability by enabling efficient purification. This strategy aids in removing host cell proteins (HCP) and viruses, reducing manufacturing costs.

Keywords:
Fc‐fusion proteinanion exchange chromatographycodon usagemanufacturabilityprotein surface charge

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Protein Engineering
  • Downstream Processing

Background:

  • Manufacturability of biotherapeutics is crucial, extending beyond drug substance stability to encompass purification efficiency.
  • Current literature often overlooks downstream process-related manufacturability, focusing instead on formulation.
  • Efficient removal of process-related impurities, such as host cell proteins (HCP) and viruses, is critical for patient safety.

Purpose of the Study:

  • To investigate the potential of modifying biotherapeutic protein surface charge to enhance downstream purification.
  • To demonstrate proof of concept for improving manufacturability through surface charge adaptation.

Main Methods:

  • Generation of engineered variants of a GLP1-receptor-agonist-Fc-domain-FGF21-fusion protein with altered surface charge characteristics.
  • Evaluation of purification efficiency using anion exchange chromatography (AEX).

Main Results:

  • Demonstrated that altering the surface charge distribution of the fusion protein enables efficient purification.
  • Showcased the feasibility of operating anion exchange chromatography at high pH, maximizing product recovery.
  • Successfully removed host cell proteins (HCP) and viruses during the purification process.

Conclusions:

  • Adapting the surface charge of biotherapeutic proteins is a viable strategy to improve manufacturability.
  • This approach facilitates efficient removal of critical impurities like HCP and viruses.
  • Optimizing surface charge can lead to more cost-effective biopharmaceutical manufacturing processes.