Delivery of biologics is an area of importance for the pharmaceutical industry. Alternatives to dosing using pre-filled syringes are being developed by a number of major pharmaceutical and drug delivery companies. 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 sterilisation. 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 sterilised or biologics (dry or aqueous) which require loading into the delivery device prior to sterilisation. For these biopharmaceuticals an alternative to aseptic processing is required.

An alternative to aseptic process is sterilisation using ionising radiation. This form of sterilisation is commonly used for medical devices not biologics because of the profound effect of ionising radiation on the structure and function of proteins. Biopharmaceuticals exposed to such radiation are denatured. However, Arecor has successfully employed its Arestat-R™ technology to maintain the integrity and function of proteins exposed to ionising radiation. The application of Arestat-R™ has been 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 ionising radiation but not after the application of Arestat-R™.

A combination of Arestat-R™ and Arestat-T™ can provide the basis of a product which can be terminally sterilised with ionising radiation and stored at ambient temperature for long periods without the loss of activity or structural integrity.