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Assessing Particle Formation of Biotherapeutics in Biological Fluids.

Joachim Schuster1, Christine E Probst2, Hanns-Christian Mahler3

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

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|January 9, 2021
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Summary

Therapeutic protein stability is crucial for patient safety. Human serum, unlike phosphate-buffered saline, effectively models in vivo conditions, revealing differences in monoclonal antibody stability and interactions.

Keywords:
Antibody stabilityIn vitro modelProtein aggregationSerumSubvisible particles

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Area of Science:

  • Biopharmaceutical development
  • Protein stability analysis
  • In vitro modeling

Background:

  • Therapeutic protein stability impacts patient safety and treatment efficacy.
  • Preclinical development requires models simulating physiological conditions for stability testing.
  • Limited public data exists on physical stability assessments of therapeutic proteins.

Purpose of the Study:

  • To evaluate the in vitro stability of fluorescently labeled monoclonal antibodies (mAbs) in human serum and phosphate-buffered saline (PBS).
  • To compare the suitability of human serum and PBS as in vitro models for predicting in vivo therapeutic protein behavior.
  • To investigate the formation and characteristics of subvisible particles in different media.

Main Methods:

  • Stability assessment of seven fluorescently labeled mAbs in human serum and PBS over five days.
  • Analysis of subvisible particles using light obscuration, flow imaging, and imaging flow cytometry.
  • Characterization of mAb-serum component interactions using fluorescence detection.

Main Results:

  • Human serum, not PBS, formed significant particles under in vitro conditions.
  • Imaging flow cytometry showed increased mAb particle size and counts in serum over time.
  • Differences in stability were observed among the evaluated mAbs, with interactions primarily with serum components.

Conclusions:

  • Human serum is a more suitable in vitro model for simulating intravenous administration conditions and evaluating therapeutic protein stability.
  • Imaging flow cytometry and fluorescence labeling can distinguish therapeutic protein particles from endogenous serum particles.
  • Understanding protein-drug interactions in serum is key for accurate stability predictions.