Technology Needs
“Cold-Chain” is often the recommended temperature-controlled supply chain, from the point of manufacture to the end-user. Freezers, coolers, warehouse and working room HVAC systems, transportation vehicles, and incremental utility expenses are examples of the cold-chain handling system necessary to assure a product’s efficacy. When any part of the cold-chain continuum lapses, products must be destroyed since performance is risked.
The Biopharma industry using temperature-sensitive drugs, vaccines, diagnostics, and blood products, is enjoying strong growth in product development and expanding market sales. Yet, the industry is confronted with rising cost pressures from payers worldwide. It costs more to keep products at refrigerated or at frozen temperatures than it does to keep them at uncontrolled ambient (room temperature) conditions. There is more to pack and transport them cold, and more to be able to demonstrate by process qualification or by measurement of each shipment that the products stay cold.
Proteins are governed by laws of thermodynamic principles. Using these principles to predict protein structure/function has been neglected in the past because of the vast complexity of thermodynamic properties. These properties have near-infinite conformational possibilities in proteins.
StableBody Technologies, LLC has created an elegantly simple, yet incredibly powerful method to solve this problem. The SBT Rational Protein Design Method, AffiBio-UIA™, utilizes a set of unique and proprietary algorithms that are derived from a computer-assisted libraries of amino acid combinations and substitutions. When these combinations and substitutions are rearranged systematically, AffiBio-UIA™ generates amino acid sequences for structurally and functionally improved antibody proteins, that are Cold Chain Free™.