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Evaluation of Crystal Zenith Microtiter Plates for High-Throughput Formulation Screening.

J Alaina Floyd1, Jeremy M Shaver1, Alison J Gillespie1

  • 1Just Biotherapeutics, Inc., Seattle, Washington 98109.

Journal of Pharmaceutical Sciences
|November 1, 2019
PubMed
Summary

Crystal Zenith (CZ) microtiter plates offer a small-volume, high-throughput alternative for biotherapeutic formulation stability studies. This system demonstrates comparable stability results to traditional vials, reducing material consumption.

Keywords:
antibody(s)automationdevelopability screeningformulationhigh throughput technology(s)protein(s)stability

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Area of Science:

  • Biopharmaceutical development
  • Formulation science
  • Analytical chemistry

Background:

  • Biotherapeutic formulation screening requires extensive material, especially for high-concentration products.
  • Traditional stability studies using vials are resource-intensive.

Purpose of the Study:

  • To evaluate Crystal Zenith (CZ) microtiter plates as a small-volume, high-throughput system for biotherapeutic formulation stability studies.
  • To compare the performance of CZ plates with traditional vials regarding evaporation, edge effects, and stability.

Main Methods:

  • Evaluated evaporation and edge effects in CZ plates with FluoroTec-coated mats.
  • Compared stability of multiple antibodies and formulations in CZ plates versus type 1 glass and CZ vials.
  • Assessed stability using high molecular weight, percent main peak, and multi-attribute methods.
  • Analyzed subvisible particle counts.

Main Results:

  • Minimal evaporation observed at 4°C; reduced at higher temperatures with sealed bags.
  • Edge effects were not significant until 12 weeks at 40°C.
  • Stability rankings (high molecular weight, main peak) were comparable between plates and vials at 4°C and 40°C up to 12 weeks.
  • Product quality attributes measured by multi-attribute method were consistent across container types.
  • CZ plates showed lower subvisible particle counts compared to vials.

Conclusions:

  • CZ microtiter plates are a viable alternative to traditional vials for small-volume, high-throughput formulation stability screening.
  • The system conserves valuable biotherapeutic material.
  • Further investigation into subvisible particle differences may be warranted.