This NSF Accelerating Innovation Research (AIR) project will establish a public-private ecosystem for the development and implementation of innovative strategies for non-destructive characterization and assessment of pharmaceutical oral dosage forms targeted to continuous manufacturing processes. Non-destructive testing also impacts the quality of health-care treatment, circumventing the issues posed by destructive testing, in which dosages given to patients can never be tested. Non-destructive testing additionally can provide a foundation to better understand critical scientific issues such as within-patient and patient-to-patient response variability since the variability associated with the manufacturing process can be de-convoluted by this approach.
Enabling non-destructive testing has significant economic impact on the quality and control of therapeutics. From an economic perspective, non-destructive testing can provide a pathway for advancing Real-Time Release Testing (RTRT), which has the potential to reduce manufacturing costs associated with large captive waiting-for-release inventories and failed batches. Moreover, non-destructive testing can provide a competitive edge for high-quality U.S.-based manufacturing by retaining and expanding U.S. manufacturing jobs in the pharmaceutical sector.
