Formulation | Industry Spotlights & Insight Articles

Freeze-Drying 2.0: Examining the Potential of Thin Film Freezing

TFF Pharmaceuticals and the Cleveland Clinic team up to advance multivalent influenza vaccine candidates into preclinical phases.

Thin Film Freezing (TFF) is a new emerging freeze-drying technique available for various treatment modalities in drug delivery. TFF Pharmaceuticals is focused on developing and commercialising innovative drugs based on its innovative Thin Film Freezing Technology platform.


Unlike other freezing methods, TFF enables the transformation of both existing compounds and new chemical entities into dry powder formulations, exhibiting unique characteristics and benefits. The ability of TFF to deliver therapies directly to the target organs such as the lungs, allows for the administration of TFF powder at lower doses compared to oral drugs.


TFF does not produce heat, stress, or other forces that can damage more complex therapeutics such as fragile biologics. Furthermore, it enables the reformulation of materials into easily stored and temperature-stable dry powders, improving accessibility of therapeutics and vaccines for global distribution. Given the piqued interest in biologics, this gives TFF a crucial edge.



TFF Pharmaceuticals has teamed up with Cleveland Clinic to advance several vaccine candidates into preclinical testing.  Funding from the National Institute of Allergy and Infectious Diseases (NIAID) and a $2.97 million Small Business Innovation Research (SBIR) grant will support this research.


This decision to pursue this project was based on the successful completion of formulation testing with stability data on the combination of hemagglutinin (HA) antigens. The purpose of this collaboration is to develop and deliver best-in-class, stable, universal, and easy-to-transport vaccines.


Ted Ross, Global Director of Vaccine Development at the Clevland Clinic added: "Over the last year, we have generated an impressive body of positive in vitro and in vivo data from these experimental influenza vaccines enabling us to further advance these promising candidates into additional in vivo preclinical efficacy studies."


According to Ross, producing a vaccine that is more than 75% effective against symptomatic influenza virus infection and protects against groups I and II influenza A viruses is the main goal. Influenza is an acute respiratory infection that causes 290,000 – 650,000 respiratory deaths annually. There is a demand to improve flu prevention and preparedness programs and significant efforts to develop more broadly protective influenza vaccines are taking place.


Although this is a promising start, this project remains in the preclinical phase and there is risk and uncertainty in transitioning from preclinical to human trials. Additionally, the extensive timeline for vaccine development could hinder potential market entry and financial returns. Furthermore, there is no guarantee that the vaccine will meet the efficacy targets outlined by preclinical studies.


Overall, this collaboration highlights the growing interest in TFF and aligns with global health priorities. The unique benefits of TFF can be used to enhance traditional delivery. If this project continues to garner success, TFF Pharmaceuticals' vaccine could offer protection against seasonal and pandemic influenza viruses and evade the need for cold chain storage.