PHARMACEUTICAL MICROSTRUCTURE SCIENCE
About digiM Solution
digiM is a microstructure science company headquartered in Woburn, Massachusetts. Founded in 2014 by Dr. Shawn Zhang, we use 3D imaging, AI analysis, and physics-based simulation to digitize drug product microstructures and predict how formulations will perform before bench experiments begin.
OUR EXPERTISE IN NUMBERS
A Decade of Digitized Pharmaceutical Development
Since 2014, digiM has partnered with pharma innovators and generic developers to digitize drug products across every major dosage form.
Drug products characterized through correlative microscopy and AI analytics
Innovator NDAs, generic ANDAs, and regulatory consulting engagements
Including many of the world's largest innovators and generic developers
Founded 2014, continuously serving pharmaceutical R and D since
THE DIGIM METHODOLOGY
Image-to-Simulation
Image-to-Simulation, or I2S, is digiM's end-to-end workflow for turning microscopy data into testable predictions of drug product behavior. Four sequential stages (imaging, analysis, quantification, and prediction) convert raw 3D images into measurable microstructure attributes and the dissolution, release, and mechanical performance they drive.
Correlative Microscopy
FIB-SEM, X-ray microCT, and optical microscopy capture drug product structure across every length scale, from nanometer API particles to whole-tablet architecture in a single study.
AI Image Analytics
Deep learning segmentation models trained on pharmaceutical microstructures separate API, excipient, polymer, and pore phases automatically, turning raw image data into structured analytical inputs.
Microstructure Quantification
Voxel-level measurement of porosity, particle size distribution, phase abundance, surface area, and tortuosity, producing the microstructure CQAs needed for development and Q3 bioequivalence documentation.
Physics-Based Performance Prediction
First-principles simulation of dissolution, release, disintegration, and mechanical behavior runs directly on voxelized microstructure, replacing weeks of bench experiments with hours of compute.
REGULATORY PARTNERSHIP
Trusted by the FDA
The U.S. Food and Drug Administration licenses digiM's I2S platform for pharmaceutical image analytics and data management. The platform is FDA 21 CFR Part 11 compliant with full audit trail support.
digiM also partners with the FDA on regulatory science research, including a contract to study the correlation between microstructures of complex long-acting drug products and their in vitro release characteristics.
2020
FDA Workshop
Dr. Zhang presents image-based microstructure bioequivalence methodology at the FDA Generic Drug Regulatory Science Initiatives workshop.
2020
FDA Research Contract
Contract awarded to study microstructure-performance correlation in complex long-acting drug products, supporting agency guidance development.
2023
FDA License
U.S. FDA subscribes to digiM's I2S platform for pharmaceutical image analytics and data management under 21 CFR Part 11 compliance.
LEADERSHIP
Led by Scientists Who Built the Field
digiM is led by a team of scientists in physics, imaging science, material science, and pharmaceutical development. With roots from Synopsys/Ansys, Thermo Fisher Scientific/FEI, Merck, Pfizer, and MGH, digiM's leadership combines decades of experience at the intersection of high-resolution imaging and computational physics.
MILESTONES
A Decade of Scientific Progress
From founding to FDA partnership, digiM's milestones reflect continuous advancement in pharmaceutical microstructure science.
WHERE WE'RE HEADED
Making Microstructure a Measurable Input
digiM is building toward a future where drug product microstructure is a measurable, predictable, and optimizable input at every stage of pharmaceutical development. Every formulation digitized becomes a reusable scientific asset. Every simulation run replaces experiments that would otherwise take weeks in the lab.
Higher-resolution imaging
Advancing correlative microscopy techniques to capture more detail at every length scale, from API particles to whole-tablet architecture.
More accurate models
Refining the physics-based simulation and generative AI models that translate microstructure data into performance predictions.
Regulatory integration
Partnering with FDA and other agencies to develop guidelines, validate methodology, and establish microstructure analytics as standard pharmaceutical practice.
WORK WITH US
Talk to Our Team About Your Drug Product
Whether you're a scientist developing a generic seeking Q3 bioequivalence, an innovator optimizing a complex formulation, or a regulator investigating microstructure-performance relationships, digiM can help.