Arestat-R™ is a unique technology that permits biologicals exposed to ionizing radiation to maintain their functional and structural integrity whether they are in solution or in a dry state. With a growing interest in drug delivery technologies applicable to biopharmaceuticals, Arecor can provide a new approach enabling novel products using these technologies to be terminally sterilized, obviating the requirement for filter sterilization, a process often incompatible with many of these technologies. Arecor has successfully applied Arestat-R™ to formulations of biologics, indwelling diagnostic devices and needle-free delivery systems.

Ionizing radiation is commonly used to sterilize medical devices. However, the exposure of biologicals in solution or in a dry state to ionizing radiation leads to the loss of structural and functional integrity through damage caused by short-lived, highly reactive species arising from the radiolysis of water and oxygen molecules. These high energy species (e.g. hydroxyl radical, hydrated electron or singlet oxygen) react with exposed and vulnerable amino acids and other functional groups, with detrimental consequences for the structure and function of biologicals.

Arestat-R™ technology stabilizes proteins by protecting vulnerable amino acids through the inclusion of protective expicients in the formulation buffer. These excipients are selected on the basis of (i) their relative reaction rates with the high energy species and (ii) their molecular structure. The excipients create an interface between key vulnerable amino acids at the protein surface and energetic products of radiolysis of water and oxygen. They act as molecular “cushions” for the protein and sacrificially absorb the impact exerted by the reactive species.

Arestat-R™ technology is protected by patent applications disclosing the use of particular types of protective compounds, defined by properties that can be determined objectively.