720305An Instrument to Simulate Subcutaneous Injection.ClosedGRD Development of PrototypeInnovate UKWe want to build an instrument to simulate what happens at the site of injection when a drug is administered subcutaneously into the human body. The instrument will be used to test newformulations, and to control the quality of manufactured batches of existing products. Many new drugs are biopharmaceuticals, such as proteins or peptides. Due to poor stability and absorption via the oral route, they can’t be taken by mouth, and the most practical way to administer them is by injection just under the skin. This method of delivery is called subcutaneous injection. Biopharmaceuticals delivered as subcutaneous injections are usually formulated as solutions containing buffers and other ingredients to improve patient comfort and product shelf-life. However, at present, the scientists involved in developing these products do not have access to a laboratory model that would allow estimating the effect of the formulation components on the bioavailability and rate of absorption of the drug from these formulations. Animal tests are used for this purpose instead, but are unpopular and don’t represent humans well. Tests with humans on the other hand are risky and expensive. To address the lack of a suitable laboratory model for subcutaneous injection, scientists at the University of Bath have developed a basic prototype of the instrument. They’ve asked Sirius Analytical Instruments Ltd., an established UK-based manufacturer to turn their idea into a robust, reliable product. Market research undertaken by Sirius Analytical, during which leading biopharmaceutical scientists were interviewed in depth, indicates a strong desire for this instrument spread over pharmaceutical and biotech companies in several countries. No other company is working in this area; it will be a unique product. The code name of the instrument is “ScISSOR” (Subcutaneous Injection Site SimulatOR). ScISSOR will be developed and manufactured in the UK. We estimate that 80% of production will be exported.