DigiM Solution LLC has received an award (Award # 75F40123P00205, in response to solicitation # FDA-23-SOL-117294) from the FDA Office of Pharmaceutical Quality (OPQ) to characterize and model microstructural quality attributes of drug products. The contract supports the OPQ’s research in adopting technologies for the manufacturing, development, and regulation of complex products. In particular, the program will support high-resolution imaging and AI analysis investigations of freeze-dried pharmaceuticals and complex products. In addition to characterization, analyzed and simulated metrics via AI and in silico dissolution models will be correlated with product performance and process parameters to identify and validate new critical quality attributes.
Dr. Andrew Clark, Director of Pharmaceutical Sciences at DigiM, spoke about the award, “Through this work with the agency, structural science and data analysis will be further integrated with the understanding of product manufacturing and quality. The program will address key questions across a variety of dosage forms and processing techniques, and serves to strengthen approaches towards manufacturing science. We are honored to work with the agency in broadening the usage of high-resolution imaging, AI, and image-based modeling to further the FDA’s grand mission. ”
The contract covers applications for freeze-dried products, polymeric long acting products including disks, implants, and ocular inserts, and topical foam products, to support orchestrated modernization of FDA’s regulatory science mission.