Press Release Summary:
- Enables up to 500 doses of vaccine to be placed on a single wafer-thin, 8.5 in. x 11 in. sheet of film, weighing one-hundredth of a pound (5g)
- Removes dependency on mass quantities of glass vials (currently in short supply) and virtually all distribution limitations
- Film stability and payload potency remain consistent at extreme temperatures and has been validated at -80º C (-112º F), 37º C (98.6º F) and 60º C (140º F)
Original Press Release:
New Thin Film Technology to Revolutionize Storage and Distribution of Biologic Treatments and Vaccines
University of Texas College of Pharmacy spawns start-up Jurata Thin Film.
AUSTIN, Texas, Sept. 29, 2020 /PRNewswire/ -- Jurata Thin Film, a company focused on revolutionizing how biologics are shipped and stored, is bringing to market a new technology that allows biologics and vaccines to be packaged, shipped and stored at room temperature for extended periods of time. The first-of-its-kind technology enables up to 500 doses of vaccine to be placed on a single wafer-thin, 8.5" x 11" sheet of film, weighing one-hundredth of a pound (5g).
Known as MSI-TX Thin Film™, the technology represents a fundamental shift in biologic packaging and storage technology that removes the need for specialized storage containers and -80º C (-140º F) freezers that today are required to ship and store biologics.
MSI-TX Thin Film also removes the dependency on mass quantities of glass vials (currently in short supply) and removes virtually all distribution limitations. If the biopharma industry embraces and successfully integrates the technology into their manufacturing and finishing processes, the result will be accelerated delivery and access to vaccines for COVID-19 and other diseases for all 7.8 billion people in the world at substantially less time and cost with the same therapeutic quality and payload potency.
MSI-TX Thin Film is a proprietary surfactant-stabilized cellulose matrix material, first published in 2015 by Maria Croyle, RPh, PhD, and her laboratory at the University of Texas College of Pharmacy, in Austin, TX. The film itself, as well as the transfer and reconstitution process have been thoroughly tested and are now ready for commercial use. This research advancement spurred the formation of Jurata Thin Film, headquartered in Chapel Hill, North Carolina, with research & development taking place in Austin, Texas.
"This is truly groundbreaking technology that can fill a critical need to meet the packaging and distribution challenges for COVID-19 vaccines," said Dr. Croyle. "8,000 uncut sheets of MSI-TX Thin Film can hold more than four million vaccine doses, can be distributed in envelopes through standard shipping methods to anywhere in the world and stored in a two-drawer file cabinet under a desk. Using current technology, this same amount of vaccine would require a 20-foot temperature-controlled container at either -20°C (-4°F) or -70°C (-94°F) to keep the vaccine viable."
In addition, MSI-TX Thin Film allows the same amount of vaccine and other biologics to be delivered at room temperature in less than one percent of packaging volumes presently required. Large films can be manufactured in about eight hours with therapeutic payload evenly distributed throughout each sheet of film. Films can be produced at any size with a wide range of dosages to elicit the appropriate therapeutic effect. The pioneering technology provides many advantages over current biologic fill, finishing and distribution methods, including:
- No loss in therapeutic potency of film stored at room temperature for up to three years with no need for specialized freezers or refrigeration
- Single dose solutions cut from film can be rehydrated in most widely used solutions in less than 15 minutes
- After rehydration, the therapeutic remains stable for eight months at room temperature
- Regardless of temperature exposure, MSI-TX provides ≥90% viral payload even through multiple freeze/thaw cycles
- Film stability and payload potency remain consistent at extreme temperatures and has been validated at -80º Celsius (-112º F), 37º Celsius (98.6º F) and 60º Celsius (140º F)
According to The International Air Transport Association (IATA), it is estimated that delivery of one dose of COVID-19 vaccines to the world's 7.8 billion people will require 8,000 jumbo jet cargo planes. As most COVID-19 vaccines in development require two doses to develop immunity, the required 15.6 billion doses needed likely doubles IATA's estimated number of cargo planes to 16,000. Based on the mass, weight and volume of doses required to meet the needs of every human on earth, Dr. Croyle adds, "We can deliver the same two dose volume of therapeutic on MSI-TX Thin Film to anywhere around the globe in four cargo planes without any specialized shipping or storage needs. That is significant."
"We are working to advance the commercial application of MSI-TX Thin Film and integrate it with manufacturing processes, thereby removing major supply chain and logistic challenges currently associated with distributing biologics," said Megan Livingston, the Director of Business Development for Jurata Thin Film. Ms. Livingston added, "Since current supply chain logistics cannot support bringing vaccines or biologics to patients, they instead may have to travel great distances to receive treatment. With this technology breakthrough, vaccines and biologics can now be delivered safely and quickly to any patient anywhere on earth."
About Jurata Thin Film
Founded in 2019, Jurata Thin Film, Inc. is a privately-held biomedical device company working to revolutionize the way vaccines and biologics are stored, distributed and delivered to all who need them around the world. Jurata's leading material, MSI-TX thin film, can be stored at room temperature for up to three years prior to reconstitution and for up eight months after reconstitution while maintaining therapeutic payload potency. MSI-TX has also been proven to protect its cargo even when exposed to extreme temperatures, as is often the case during shipping and distribution. This technology could remove the need for cold chain logistics in vaccine and biologic transport and storage, while exponentially reducing the space required to store these lifesaving therapies. Parties interested in learning more about or partnering with Jurata Thin Film should visit www.juratatf.com for additional information.