Eradicating the Need for Cold-Chain Distribution in the Biopharmaceutical Industry

Cold chain distribution is complicated and critical for formulations that must be kept in very cold temperatures in the pharmaceutical industry, since their stability decreases quickly at room temperatures. The World Health Organization (WHO) has reported over 50% of vaccines are wasted and must be disposed of globally every year due in part to disruption of the cold chain distribution and lack the resources to support the ultracold temperature requirements. A possible solution to the existing problem is Hyalo Technologies’ Hyalo Matrix sterilization method. Cold chain logistics could be eliminated by allowing for room temperature product stability, storage and transport. This method also has the ability to sterilize pharmaceutical products and medical devices at lower temperatures, which prevents product denaturation, maintains efficacy, and increases shelf life of the products. After the Hyalo matrix is added to a product it can be sterilized at the end of a manufacturing process, which will do away with the need for aseptic processing in sterile rooms.

Sterilization with the Hyalo matrix is a method that adds a matrix to pharmaceutical products and medical devices and sterilizes them at a lower temperature, prevents product denaturation, maintains efficacy, and enhances stability. This method is applicable and seen favorable results with genetic materials, biologics, antibodies, biosimilars and various drug delivery systems. The Hyalo matrix could eradicate the need of cold chain logistics for storage and transportation as the product is now stable at room temperature. It also eliminates the need for aseptic processing and specialized sterile rooms, allowing for sterilization to occur at the end of manufacturing process, which will reduce time and cost. Both of these improvements will significantly reduce cost of manufacturing, transportation, storage and distribution of the product and save hundreds of millions of dollars for individual organizations and billions of dollars across the industry.

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