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Marcus R Estrada1, Anan Bzami1, Elizabeth B Norton2

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PubMed
Summary

Adding polysorbate 80 (PS80) to double mutant heat-labile toxin (dmLT) improved its stability. This formulation allows for a more clinically relevant concentration, reducing wastage of this novel vaccine adjuvant.

Keywords:
AdjuvantE.coli heat-labile toxinFormulationdmLT

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Area of Science:

  • Vaccinology
  • Biochemistry
  • Formulation Science

Background:

  • Double mutant heat-labile toxin (dmLT) is an emerging vaccine adjuvant.
  • Current dmLT formulations require high dilution for vaccine use, leading to material waste.
  • Need for a stabilized dmLT formulation at a clinically relevant concentration.

Purpose of the Study:

  • To improve the stability of bulk double mutant heat-labile toxin (dmLT) at a higher concentration (20 µg/mL).
  • To achieve this with minimal modifications to the existing dmLT formulation.
  • To evaluate the impact of excipient addition on dmLT stability.

Main Methods:

  • Lyophilization of dmLT formulations.
  • Short-term accelerated stability studies at elevated temperatures (40°C).
  • In vitro assessment of dmLT stability post-formulation and lyophilization.

Main Results:

  • The addition of 0.05% polysorbate 80 (PS80) to the dmLT formulation enhanced stability.
  • Lyophilized dmLT at 20 µg/mL with PS80 remained stable for 4 weeks at 40°C.
  • PS80 was identified as a key excipient for stabilizing dmLT.

Conclusions:

  • A modified dmLT formulation containing 0.05% PS80 demonstrates improved stability at a clinically relevant concentration.
  • This formulation strategy can reduce adjuvant wastage and facilitate vaccine development.
  • Further studies are warranted to confirm long-term stability and in vivo efficacy.