founder and managing director of DigiM DigiM Solution LLC Woburn, Massachusetts
The quality and performance of drug products rely on the internal microstructures. From API size distribution to the spatial arrangement of excipients, there is a large matrix of important microstructural attributes that can be quantified and aid in a quality by design approach. In particular, the wide array of formulation techniques and their library of parameters are ideally suited for studies through the lens of imaging. As the technology leader in this space, DigiM has pioneered a suite of high-resolution imaging techniques, AI analysis, and in silico dissolution models to transform drug products and intermediates into a library of reusable digital twins. The quantified critical quality attributes (CQAs) and verified in silico models can be developed into mechanistic and predictive formulation via microstructure digital twins, which act as an integral part in drug product understanding. These learnings and models can be further applied in the process development of future products and intermediates. In this presentation, examples of AI powered transformation applied in the formulation development of complex oral solid dosage forms, controlled release products, and nanocarriers will be reviewed. The use of a family of easy to use web apps based on DigiM I2S, an image data management and microstructure engineering platform powered by generative AI, will also be discussed in both drug development and regulatory support contexts.
Learning Objectives:
Upon completion, participants will be introduced to the microstructure challenges in drug development.
Upon completion, participants will learn the novel techniques in correlative microstructure imaging.
Upon completion, participants will appreciate the power of AI models in converting microstructure images into quantifiable CQAs.
Upon completion, participants will understand the vital role of predictive in silico modeling to enable and shorten drug product development.
Upon completion, participants will be exposed to a variety of regulatory support considerations related to microstructures including bioequivalence assessment, Scale-up and Post-Approval Changes Guidance, and continuous manufacturing development where cGMP of data, AI, and models are of paramount importance.