Feasibility Arrangement for Shelf-stable Powder Form of Messenger RNA COVID-19 Vaccine Candidate Announced by GreenLight Biosciences and TFF Pharmaceuticals
GreenLight Biosciences, Inc., a privately-held RNA vaccine developer and manufacturer, and TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that the two biotech companies have partnered for feasibility studies aimed at opening broader global vaccine distribution through production of a shelf-stable powder form of messenger RNA COVID-19 vaccine that would be easily reconstituted prior to injection and not require the extreme cold chain of current RNA vaccines.
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While messenger RNA COVID-19 vaccines have proved among the fastest to develop, produce and adapt to new variants of concern, maintaining stability has required supply chain temperatures for some vaccines as low as -80°C (-112°F).
This requirement for extreme cold increases distribution complexity, cost and also constrains vaccine distribution to regions and countries with limited cold chain infrastructure.
To address this challenge, GreenLight Biosciences and TFF Pharmaceuticals have entered into a feasibility and material transfer agreement to evaluate a shelf-stable dry powder formulation of GreenLight’s COVID-19 messenger RNA vaccine candidate.
“We are excited to partner with GreenLight Biosciences on their unique messenger RNA production platform,” said Glenn Mattes, President & CEO of TFF Pharmaceuticals. “Their platform technology represents a breakthrough in efficient production of messenger RNA vaccines, and by combining both of our technologies, this collaboration could be a real game changer for people around the world suffering through this pandemic.”
Should the feasibility study prove successful, a further stage of work will include non-needle administration methods for the GreenLight mRNA vaccine candidate in a dry powder form that could be administered via nasal spray or lung inhalation.
Under the Feasibility Agreement, GreenLight Biosciences is delivering its COVID-19 messenger RNA product candidate materials to TFF in order to perform feasibility formulation work and testing.
The goal of this feasibility work is to formulate and identify an optimal formulation of the GreenLight Biosciences messenger RNA product candidate in a dry powder form, which has superior stability, maintains particle size of the encapsulated messenger RNA as well as high encapsulation efficiency and has rapid reconstitution characteristics for injection.