We had a great year for groundbreaking work in the pharmaceutical industry. Working with our partners, we applied our microstructure image analysis to take the biggest challenges in pharmaceutical material characterization, formulation development, process development, and product design. See below for a recap of our collaborations and work in 2019 and onward.
DigiM has received a contract from the FDA to develop a framework for accelerating release evaluation of sustained release formulations using microstructure image analysis. The project, in collaboration with the laboratory of Prof. Diane J. Burgess at the University of Connecticut, will seek to establish correlations between microstructure features and in vitro release characteristics. Read more here.
In a joint paper with Genentech, Lonza, and Roche, DigiM segmented and quantified the volume of tablet defects for tablets processed under different conditions and compositions. The study demonstrates a practical approach towards quantifying and gaining a mechanistic understanding of formation of defects, which is crucial for quality-by-design. Read the abstract and obtain full access here. Reach out for more info about this project.
At PharmSci 360 in San Antonio, DigiM presented an invited talk and two posters on applications of microstructure image analysis. DigiM’s founder Shawn Zhang presented on the application of quantitative image analysis and release simulations for controlled release microspheres. You can request slides from the talk. Collaborating with Eli Lilly, DigiM presented a poster on the characterization of spray-dried aggregates with 3D imaging analysis. Another poster, in collaboration with BMS and Moderna, highlighted the use of non-invasive X-Ray microscopy and quantitative image processing to analyze a lyophilized protein cake. Request access to these posters.
DigiM also co-hosted the China Discussion Group Dinner Reception with Novagenesis Therapeutix, welcoming over 200 scientists from worldwide for discussion and networking.
In May, DigiM attended and presented at the workshop on Dissolution, Bioequivalence, Product Performance and Quality Workshop in Shandong, China. DigiM’s Dr. Liping Zhou presented on the mechanistic characterization of drug release behavior from 3D images. Our collaborators from Merck presented on the application of 3D imaging analysis towards sustained release delivery systems.
DigiM’s analysis of tablet defects with image processing was featured in a talk from our collaborators at Genentech. The presentation featured a quantitative approach to evaluate roles of process condition and formulation in forming defects.
DigiM’s Dr. Shawn Zhang gave an invited presentation at the GRC’s summit on Preclinical Form and Formulation for Drug Discovery. Shawn’s talk, “Image-Based 3D Drug Microstructure Characterization and Release Dynamics Optimization,” is available for request here.
DigiM’s technology was featured in a talk given by our collaborators at Genentech. The talk focused on the challenges in CMC for ocular drug-delivery technologies.
At the Applied Pharmaceutical Analysis meeting, DigiM was recognized for best poster on the application of high-resolution 3D imaging in characterizing drug substances and products. The poster features analysis on lyophilized protein cake, spray dried particles, and PLGA microspheres. Request the poster here.
We look forward to meeting you at these conferences in 2020: