Feasibility arrangement to test GreenLight Bioscience Inc’s COVID-19 messenger RNA vaccine candidate as a shelf-stable dry powder formulation using
An easily reconstituted and shelf-stable dry powder formulation of messenger RNA COVID-19 vaccine could overcome the extreme low temperature cold chain requirements for current RNA vaccines.
Eliminating extreme cold from the supply chain simplifies global distribution and opens vaccine availability to the large populations in regions and countries with limited refrigeration infrastructure
Should the study prove successful, the next phase may include non-needle administration of mRNA vaccines, including nasal spray and lung inhalation form.
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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,
“We are excited to partner with GreenLight Biosciences on their unique messenger RNA production platform,” said
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.
If successful, this should make messenger RNA vaccines available to the whole world, simplifying cold-chain supply challenges. Thin film technology potentially allows vaccines to be transported at fridge, or even room temperatures as a powder. It can then be reconstituted by a health care worker at the point of use.
This agreement is part of GreenLight Biosciences goal of using its unique manufacturing platform to produce vaccines in volumes that can serve the world’s need for billions of doses. This partnership offers the hope of speeding these doses into use.
“Overcoming the COVID-19 pandemic requires a large volume of second generation vaccines that adapt rapidly and can be delivered to all parts of the world, regardless of local cold chain infrastructure,” said
TFF has two drug candidates in phase one clinical trials, Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. TFF requires approximately six weeks from receipt of materials to prepare an initial dry powder form of GreenLight’s vaccine candidate to test for reconstitutability and viability.
GreenLight Biosciences has several messenger RNA Covid vaccine candidates in development built off of GreenLight’s manufacturing platform, which delivers high-quality RNA at a lower cost and higher speed than comparable processes.
GreenLight is a bio-performance company with a unique, cell-free production platform that delivers high-performing RNA solutions to human, plant and animal challenges. GreenLight develops RNA products for plant and life science applications, and collaborates with industry leaders to advance vaccine development, pandemic preparation, crop management, and plant protection. The GreenLight team is committed to social justice, diversity, inclusion, and equality, and promises to use collaboration to remain scientifically imaginative and passionately focused on making a difference in the world. For more information, visit https://www.greenlightbiosciences.com/.
About TFF Pharmaceuticals’ Thin Film Freezing technology platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.
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