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Development of a Candidate Stabilizing Formulation for Bulk Storage of a Double Mutant Heat Labile Toxin (dmLT) Protein Based Adjuvant

Systematic formulation development studies are critical to minimizing instability and maintaining or augmenting the potency of adjuvants. This article, published in Vaccine, describes the formulation design and development of a double mutant heat labile toxin (dmLT), a novel protein-based adjuvant. This involved identifying pharmaceutical excipients that enhanced dmLT stability with an end goal of developing a more stable bulk dmLT formulation that does not require lyophilization. The study outcomes provide flexibility for future use of dmLT, though further pharmaceutical development of the adjuvant in the new candidate bulk formulation will require long-term bulk storage stability studies and compatibility testing with different vaccine antigens in a final drug product.

Author: Toprani VM, Sahni N, Hickey JM, et al.

Published: 2017

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(Located at www.sciencedirect.com)

Citation: Toprani VM, Sahni N, Hickey JM, et al. Development of a Candidate Stabilizing Formulation for Bulk Storage of a Double Mutant Heat Labile Toxin (dmLT) Protein Based Adjuvant. Vaccine. 2017;Early Online Publication.

Resource types: Peer-reviewed journal

Diseases/vaccines: Not disease/vaccine specific

Topics: Vaccine stabilization and formulation

Regions: Global