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Analytical Challenges Assessing Protein Aggregation and Fragmentation Under Physiologic Conditions.

Joachim Schuster1, Hanns-Christian Mahler2, Susanne Joerg2

  • 1Lonza Pharma and Biotech, Drug Product Services, Basel, Switzerland; University of Basel, Pharmacenter, Division of Pharmaceutical Technology, Basel, Switzerland.

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PubMed
Summary

Assessing therapeutic protein stability in vivo is challenging. This review explores analytical methods to evaluate protein aggregation and fragmentation in biologic fluids, aiding drug development.

Keywords:
Analytical biochemistryIn vitro model(s)Monoclonal antibody(s)Protein aggregationStability

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Area of Science:

  • Biopharmaceutical Development
  • Protein Chemistry
  • Analytical Chemistry

Background:

  • Therapeutic proteins administered via injection/infusion face physiological challenges impacting stability.
  • Protein aggregation and fragmentation are critical quality attributes affecting drug safety and efficacy.
  • In vivo protein stability assessment is gaining attention but remains difficult to investigate.

Purpose of the Study:

  • To review analytical approaches for assessing therapeutic protein stability under simulated physiological conditions.
  • To discuss factors contributing to in vivo protein aggregation, precipitation, and fragmentation in biological fluids.
  • To evaluate the applicability and limitations of current analytical methods for in vivo protein degradation studies.

Main Methods:

  • Review of analytical techniques for assessing protein stability in simulated physiological environments.
  • Discussion of factors influencing protein degradation in complex biological matrices.
  • Evaluation of methods for circumventing matrix interference, such as protein purification or labeling.

Main Results:

  • Current analytical methods for in vivo protein stability assessment have limitations.
  • Protein aggregation and fragmentation in biological fluids are complex phenomena.
  • Specific analytical approaches are better suited for certain degradation events.

Conclusions:

  • Improved analytical methods are crucial for understanding in vivo protein aggregation and fragmentation.
  • In vitro models can aid in selecting drug candidates and accelerating preclinical development.
  • Further research is needed to accurately track therapeutic protein stability in biological fluids.