Physical Sciences Inc. in collaboration with the University of Connecticut and SP Scientific will develop a combined hardware/software product that will enable pharmaceutical scientists to rapidly develop robust product freeze drying cycles on both laboratory and production scale lyophilizers. The product development will be accomplished through the combination of software enabling communication between a Tunable Diode Laser Absorption Spectroscopy (TDLAS) water vapor mass flow rate sensor and a process control algorithm based upon a heat and mass transfer model of vial freeze drying. Sensor enabled water vapor mass flow rate determinations combined with the model will enable non-intrusive determination of product temperature during drying, a key process parameter. Product temperature determinations will provide a process control parameter for developing and controlling freeze drying during laboratory, pilot and production scale freeze drying. The proposed process development software will save pharmaceutical customers months of time in developing their process design space and an optimum cycle. The process control software will enable real-time monitoring and control that could also shorten the primary drying process time. This is significant since primary drying is the longest part of the lyophilization process and can last for days. Following the software development extensive laboratory experimentation will be carried out at the University of Connecticut and SP Scientific to assess measurement accuracy and automated process cycle control for the development of optimized drying operations. A standard operating procedure for lyophilization process scale-up and process control will be developed based on the use of the product.
The development of biologic pharmaceutical products, the fastest growing segment within the pharmaceutical industry, often requires formulations that must be freeze dried to stabilize labile products so they can be stored, shipped and reconstituted for use. The development of economically viable drying processes that produce high quality product is critical for the success of these drug products and is one element of drug cost control. This R&D proposal directly addresses this aspect of pharmaceutical manufacturing and will result in a product that will be used by process development scientists and production staff at pharmaceutical companies. This proposed program supports the USFDA Process Analytical Technology (PAT) initiative, the industry Quality by Design (QbD) initiative and Executive Order 13329 to modernize pharmaceutical manufacturing. This project also advances research and education via the collaboration with the University of Connecticut, a leading US pharmaceutical manufacturing research and teaching institution affiliated with the industry and NSF-initiated Center for Pharmaceutical Processing Research (CPPR).
