Helena is supporting a new technology that addresses the cold-chain problem. Dynashield is a polymer system that stabilizes temperature-sensitive proteins for long term long-term storage, potentially eliminating the need for the use of freezing or glycol.
The technology was developed by Nanoly, a leading biotechnology company co-founded by Helena Member Nanxi Liu. Nanoly and Helena are partnering to release Dynashield at no cost for use in vaccines, biologics, therapeutics, or other critical treatments needed to respond to global pandemics like COVID-19.
Transporting life-saving medical treatments around the world is no easy feat. Beyond the immense logistical complexity of coordinating the transportation of billions of individual medical goods, there is another challenge — many of these goods are temperature-sensitive.
That means they can break or become damaged when they come into contact with temperatures outside of a specific range. To ensure that this doesn’t happen, the good must somehow be kept in a specific, often refrigerated environment through the entire “chain” of events that stretches from its creation in a laboratory to its final use on the other side of the world. The global system of sustaining this temperature control is called the “cold-chain.”
The cold-chain is a massive industry. In 2020, it had an estimated market size of $233.8B and by 2025 it is projected to grow to $340.3B. It is also a significant emitter of carbon-dioxide. Refrigeration has been identified as one of the most important sectors to decarbonize in order to address climate change, a goal that will be challenging to fulfill with an ever-increasing reliance on the cold-chain.
The onset of a global pandemic like COVID-19 adds considerably more pressure to the cold-chain for the transportation of critical medical treatments.
Even prior to the COVID pandemic, the World Health Organization estimated that 50% of vaccines may be wasted each year because of temperature control, logistics, and shipment-related issues. Breaks in the cold chain are cited as a major constraining factor in achieving universal immunization coverage and, as a result, leaving millions of people under-vaccinated across the globe and disease elimination and eradication harder to achieve.
COVID has only accelerated the immediacy and negative repercussions of these problems. Responding to COVID and future global pandemics will amount to some of the largest logistical efforts in human history. They require producing, shipping and administering treatments from vaccines, biologics and therapeutics to billions of people, large portions of which are in remote, hot-climate geographies.
Then there is cost. Sustaining a cold chain requires resources that are not always available to medical facilities, especially in underserved communities and the developing world. While wealthy nations, well-financed private corporations and NGOs are able to afford the costs, many communities won’t. While this was already a significant problem prior to COVID, the exponentially increased need for temperature-sensitive medical treatments as a result of global pandemics only exacerbates the problem.
A better solution is overdue. A reliable, cheaper, and less carbon intensive solution to the cold chain problem is not just superior for the bottom line, but will further the goal of universal health equity and reduced emissions.
Dynashield, a new technology developed by bioscience firm Nanoly, is a highly promising alternative.
Dynashield is a polymer system that encapsulates molecules in a hydrogel matrix which shields from forces causing degradation. Technologies of this kind are often known as “excipients” or “additives.”
At the point of use, molecules are released from NanoShield by photo-triggered degradation of the hydrogel by exposure to a specific wavelength of benign, low-intensity light for a short period of time. After these molecules are released, all that remains is soluble polyethylene glycol (known as PEG) and the cargo molecule now ready for use.
Each component of DynaShield has been FDA approved. The base polymer, polyethylene glycol, is FDA approved for both injection and oral consumption and is on the FDA’s inactive ingredient list, classified as a generally recognized as safe (GRAS) compound. However, companies that use DynaShield in their products must still test the product combined with DynaShield and take it through the FDA approval path.
Project Cold Chain is a non-profit Helena project. Its sole purpose is to further the development and implementation of DynaShield.
In partnership with Nanoly, Helena is working to offer the use of DynaShield at no cost, for any developer of medical treatments for COVID-related uses, including but not limited to vaccines, biologics and therapeutics.
Dyanshield’s next step is continued advanced testing and early deployment. Developers looking to utilize the technology will incorporate it into their treatments as those treatments seek FDA approval.
In August of 2022, Dynashield was validated in the peer-reviewed journal, Science Advances. Co-authored by Nanoly co-founder Balaji Sridhar, the paper outlines the wide-range of successful use cases for Dynashield’s core technology, including model enzymes, heat-sensitive clinical diagnostic enzymes, protein-based vaccines, and whole viruses. The authors’ research demonstrates sustained thermo-stabilization of biologics – defined as biologically derived complex macro molecules used as pharmaceutical products – at temperatures ranging from 27 to 65 degrees Celsius. (Critically the easily reversible hydrogel technology also allows for on-demand recovery of the biologics when ready for use.) Furthermore, the data suggests that the component materials of the hydrogel are safe for human metabolization.
The peer-validated findings mark a significant milestone on the path to implementing Dynashield in the field – an outcome that would create opportunities for a more robust global health response to ongoing and future pandemics.
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