Delivery of biologics is an area of importance for the pharmaceutical industry. Potential applications include drug-eluting stents, nasal delivery, pulmonary and oral delivery of biopharmaceuticals. However, in many of these applications an efficient and viable production process is a key barrier to product development.

One of the constraints of combining biologics with delivery devices is sterilization. Typically, sterility of biologics is achieved through aseptic manufacturing involving filtration and sterile filling. In some cases this is not feasible. There are solid dose forms which cannot be filter sterilized or biologics (dry or aqueous) which require loading into the delivery device prior to sterilization. For these biopharmaceuticals an alternative to aseptic processing is required, such as sterilization using ionizing radiation.

Usually, biologics exposed to ionising radiation are denatured. However, Arecor has successfully employed its Arestat-R™ technology to maintain the integrity and function of proteins in these circumstances. The application of Arestat-R™ was first validated in a wound dressing, Oxyzyme™ which has been approved as a Class III medical device in the European Community. Oxyzyme™ contains an active enzyme, Glucose Oxidase, which readily degrades upon exposure to ionizing radiation but not after formulation with Arestat-R™.