Heat stable and intrinsically sterile liquid protein formulations

Area of Science:

• Biochemistry
• Materials Science
• Pharmaceutical Sciences

Background:

• Biologics and vaccines require strict cold chain management (80-90%) to prevent degradation.
• Current cold chain logistics are expensive, complex, and unsuitable for remote areas.

Purpose of the Study:

• To develop a novel formulation for protein-based therapeutics that eliminates the need for cold chain storage.
• To create thermally stable, non-aqueous protein formulations using chemical dispersants and fluorous liquids.

Main Methods:

• Chemical dispersants were used to solvate proteins in fluorous liquids, altering thermodynamic equilibrium.
• Protein conformational flexibility was reduced to enhance structural rigidity.
• Non-aqueous, fluorine-based liquid formulations were created and tested for thermal stability and contamination resistance.

Main Results:

• Formulations demonstrated thermal stability up to 90°C.
• The non-aqueous formulations were resistant to microbial contamination, enzymes, and impurities.
• Pre-clinical pharmacokinetics and safety profiles were comparable to standard saline formulations.

Conclusions:

• A novel fluorochemical formulation paradigm was established for protein reagents and biopharmaceuticals.
• This approach offers a potential solution to overcome cold chain limitations in biologic drug and vaccine supply chains.
• The developed formulations enhance the stability and accessibility of temperature-sensitive protein-based therapeutics.