Ionising radiation is commonly used to sterilise medical devices.
However, the exposure of biologics to ionising 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 biologics. Arestat-R™ is a unique technology
that permits biologics exposed to ionising radiation to maintain
their functional and structural integrity.
Arestat-R™ technology stabilises proteins through the inclusion of
protective excipients in the formulation. 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.
With a growing interest in drug delivery technologies applicable to
biopharmaceuticals, Arecor can provide a new approach enabling novel
products using these technologies, obviating the requirement for aseptic
processing or filter sterilisation, processes often incompatible with many
of these technologies. Arecor has successfully applied Arestat-R™ to
formulation of liquid and dry biologics, indwelling diagnostic devices and
needle-free delivery systems.