The goal of the proposed SBIR program is to develop lyophilizer manufacturing hardware and processing procedures that enable the efficient freeze drying of pharmaceutical product formulations in prefilled syringes. The use of prefilled syringes 1) reduces dosing and medication errors, 2) reduces the risk of microbial contamination, 3) improves dosing accuracy, 4) reduces waste by eliminating the need for vial overfill, 5) increases convenience and reduces the time required for emergency use and 6) improves the ease of administration for the healthcare profession and patient. Unfortunately, very few lyophilized drugs are provided in prefilled syringes due, in part, to the challenges associated with producing high quality freeze dried drug product in single or dual chamber syringes. The difficulty of freeze drying in prefilled syringes is primarily due to the poor heat transfer betwee the temperature controlled dryer shelves and the syringes due to the odd shape of the container system. During this proposed R&D program Physical Sciences Inc. will collaborate with the University of Connecticut, School of Pharmacy and IMA Life, NA to develop new freeze dryer hardware and processing procedures that enable efficient lyophilization of representative pharmaceutical formulations, including biological drug formulations, in syringes. This project supports the NIH goal of developing scale-up and manufacturing technology for pharmaceuticals and also supports Executive Order 13329 targeted at improving U.S. manufacturing competitiveness in critical economic sectors, such as the pharmaceutical industry.
The research will provide new lyophilizer hardware and processes that enable efficient freeze drying and the production of high quality drug products, including vaccines and anticancer therapies, in prefilled syringes. The use of prefilled syringes will improve the safety, efficiency and accuracy of freeze dried drug administration to patients.