Helena Offers Polymer Solution to Global Cold Chain Issues for COVID-19 Vaccines, Biologics, and Therapeutics

Helena, a provider of solutions for global societal problems, announced a collaboration with Nanoly Bioscience, a biotechnology company, on Dec. 16, 2020 to offer the biotech company’s innovative, temperature-stabilizing polymer, DynaShield, at no cost to COVID-19 vaccine, biologic, and therapeutics developers.

DynaShield provides a potential solution to the cold chain challenge currently experienced by many companies and nonprofits in the biotech and pharma arenas, Helena stated in a company press release. The polymer technology allows sensitive proteins to be stored long-term without freezing or glycerol. By providing it at no cost, developers will be able to incorporate the polymer into their products and test the technology as they seek FDA approval.

The DynaShield polymer works by encapsulating vaccines, biologics, or therapeutics in a gel network that stabilizes them from variations in temperature. By providing this stability, the polymer simplifies storage and delivery processes, reduces waste, improves efficacy, and increases society’s collective chance of getting COVID-19 under control, according to Helena. The DynaShield technology could potentially remove the barriers posed by the need for refrigeration or other temperature-control methods and would allow better access to COVID-19 vaccines and therapeutics.

Each component of DynaShield is FDA approved. Polyethylene glycol (PEG), the base polymer, is FDA approved for both injection and oral consumption and is on the agency’s inactive ingredient list. PEG is classified as a generally recognized as safe (GRAS) compound, but companies that use DynaShield in their products must still test their product combined with DynaShield and take it through the FDA approval path.

The World Health Organization estimates 50% of vaccines may be wasted each year because of temperature control, logistics, and shipment-related issues, Helene reported in its press release. Vaccines, biologics, and therapeutics are delicate in nature and require proper storage throughout the product lifecycle. If exposed to extreme conditions including high heat or freezing temperatures, the treatment can lose its potency. Sustaining a cold chain requires precise coordination and extensive resources that are not always available to medical facilities, especially in underserved communities and the developing world, the company said. The cold chain is 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 making the eradication of disease much harder to achieve.

“COVID-19 has laid bare so many previously under-prioritized global problems—especially those which disproportionately affect economically disadvantaged communities. The cold chain is one of them. Relying on refrigeration alone to distribute critical medical treatments to billions of people just isn’t a sustainable solution for the coming future. We have to innovate better,” explained Henry Elkus, founder and CEO of Helena, in the press release. “Our hope with this project is that releasing DynaShield for free to developers of COVID biologics, therapeutics, or vaccines will make it more likely that these treatments reach populations around the world where the cold-chain is inefficient or ineffective. In the longer term, we hope to contribute to a more equitable global system that lowers the economic and geographic barriers to receiving life-saving treatments.”

“DynaShield is the first technology to stabilize viral vectors in a physically immobilized network,” said Nanoly Bioscience Co-Founder and Helena Member, Nanxi Liu, in the press release. “The covalent network around the polymer stabilizes vaccines better than conventional excipients currently used.”

Helena and Nanoly Bioscience are offering support to those who choose to incorporate and test DynaShield and to help combine products efficiently and effectively. The companies will provide critical support to developers that need to incorporate the polymer successfully into existing vaccine molecules and will help to make the process of incorporating this polymer technology as easy and efficient as possible. DynaShield is not currently used in any on-the-market vaccines, biologics, or therapeutics. Internal studies have shown, however, that the polymer stabilizes components of various viral vectors, including influenza and adenovirus.

Source: Helena