DigiM Solution

Changing the World, One Image at a Time

Your Partner in Drug Product Characterization

Microstructures are at the core of drug products and modern delivery systems. At DigiM, we apply a suite of microstructure analysis tools to accelerate formulation design, process optimization, performance troubleshooting, and regulatory filings.

Explore Solutions for Drug Development

Controlled Release and Long-acting

By reimagining imaging as a tool that can be both quantitative and predictive, our image-based platform has served as a game changer for the development of controlled release and long-acting dosage forms.

Accelerate Development with Predictive Simulation

Formulation Development

Whether its selecting the dosage form, optimal drug loading, or compatible excipients, drug formulation can be a lengthy process. Optimizing these formulation choices is key for developing a drug product that can be used for phase III clinical trials, batch release testing, and ultimate market release.

Explore Solutions for Formulation Selection

Process Development

Drug product development includes a complex and wide range of processes, from the drug substance, processing of intermediates, and the manufacturing of the final drug product. These steps must be optimized to ensure both consistent quality and methodologies that can be brought to scale.

Microstructure Answers for Process Engineering

Materials Science Applications

At DigiM, we work with material scientists hand-in-hand to improve industrial and consumer material development through non-destructive imaging and AI image analysis.

Solutions for NDT and Image Analysis

Geoscience Applications

At DigiM, we aid petrophysical assessment on reservoir quality and transport potential through systematic and validated digital rock physics software tools.

Solutions for Petrophysical Analysis

Encounter DigiM

Press Release and News

Stay tuned for a preview of the many presentations for the upcoming 2022 AAPS PharmSci 360 conference.
Learn about characterization solutions for solid dosage forms at our posters presented at the 2021 AAPS PharmSci 360 conference.
At the 2021 CRS Meeting, we are proud to present our work using high-resolution 3D imaging, AI analytics, and image-based simulations. In collaboration with our clients, we demonstrated how image analysis can assess the impact of microstructures on the performance of long-acting implants and injectables. Learn more here.
At AAPS-NERDG 2021 Annual Meeting, DigiM gave a rapid fire presentation titled: “Digital drug formulation and design: critical insights from microstructure imaging”. Read about our work here.
In collaboration with FDA, DigiM participated in several presentations at IFPAC 2021 Annual Meeting to evaluate container closure system effects on lyophilized products. Click here to learn more.
In the AIChE 2021 Annual Meeting, DigiM talked about how digital images, when quantified and analyzed with AI machine learning algorithms, can help understand the process, performance, and formulation design of drugs. Learn about our work here.
DigiM gave several talks and posters covering our AI image analytics and simulation to quantify and characterize drug products of all kinds at the AAPS PharmSci 360 event. Read more about our work here.
At the CRS 2020 Annual meeting, DigiM presented our latest drug release simulations for PLGA microspheres, long-acting implants and more. Click here to learn more.
DigiM Awarded FDA Contract to Study Microstructure Bioequivalence of Polymer-based Long-acting Drugs (in collaboration with Dr. Diane Burgess’ Laboratory at UConn). Read the press release here. Medical News press release available here.
DigiM’s Quantitative Image Characterization Featured in FDA Workshop. Watch the presentation and read the press release here. AZO Materials press release available here.

Upcoming Events

Pharmaceutical

American Association of Pharmaceutical Scientists (AAPS) 2022 Annual Meeting and Exposition
Boston, Massachusetts – 10/15-10/18

Release Mechanism and Performance Prediction of a Multi-Block Copolymer-Based Long-Acting Reversible Contraceptive (LARC) Implant
Poster Number: W0930-12-67
Presented by Andrew Clark in collaboration with Innocore Pharmaceuticals

Seeing is Believing: A Microscopic “Google Earth” View of Extended-Release Claritin Formulation
Poster Number: T1530-06-34
Presented by Phil Yawman

Correlating Tablet Performance Differences to Tablet Microstructure Using MFV-SEM and XRM Imaging Coupled with AI Image Analytics
Poster Number: T0930-08-46
Presented by Phil Yawman in collaboration with Janssen Pharmaceuticals

Advanced Microstructure Characterization of Extended-Release Claritin Formulations
Rapid Fire Talk at Session: Rapid Fire: Analytical and Predictive Approaches in Drug Development and Manufacturing
Rm 205C Monday 10/17 at 3:00 pm
Presented by Phil Yawman

Assessing the Interrelationship of Microstructure, Properties, Drug Release Performance, and Preparation Process for Amorphous Solid Dispersions
Poster Number: M1230-07-38
Presented by Hao Helen Hou at Genentech in collaboration with DigiM

Effect of Coacervation Processing Parameters on In vitro Drug Release from Minocycline HCl Microspheres
Poster Number: M0330-04-23
Presented by Ruifeng Wang at UCONN in collaboration with DigiM and FDA

Effect of Coacervation Processing Parameters on In vitro Drug Release from Minocycline HCl Microspheres
Poster Number: M1330-03-15
Presented by Yun-Chu Chen at Purdue University in collaboration with DigiM

Recent Presentations and Publications

Press Release and News

Stay tuned for a preview of the many presentations for the upcoming 2022 AAPS PharmSci 360 conference.

Read about our presentations at 2021 AAPS PharmSci 360!
Learn about characterization solutions for solid dosage forms at our presentations where we examined microsphere and implant microstructure and drug release.

View our 2021 CRS Annual Meeting presentations!
At the 2021 CRS Annual Meeting, we are proud to present our work using high-resolution 3D imaging, AI analytics, and image-based simulations. In collaboration with our clients, we demonstrated how image analysis can assess the impact of microstructures on the performance of long-acting implants and injectables. Learn more here.

Learn about Digital Drug Formulation and Design from our rapid fire talk presented at the 2021 AAPS-NERDG Annual Meeting.
At AAPS-NERDG 2021 Annual Meeting, DigiM gave a rapid fire presentation titled: “Digital drug formulation and design: critical insights from microstructure imaging”. Read and watch about it here.

In collaboration with the FDA, DigiM’s work on lyophilized solids presented at the 2021 IFPAC Annual Meeting.
DigiM participated in several presentations at IFPAC 2021 Annual Meeting in collaboration with the FDA to evaluate container closure system effects on lyophilized products. Click here to learn more.

At the 2021 AIChE Annual meeting, DigiM showcased imaging characterization of drug products and its impact on drug design and performance.
In the AIChE 2021 Annual Meeting, DigiM talked about how digital images, when quantified and analyzed with AI machine learning algorithms, can help understand the process, performance, and formulation design of drugs. Learn about our work here.

Check out DigiM’s presentations at 2020 AAPS PharmSci 360!
DigiM gave several talks and posters covering our AI image analytics and simulation to quantify and characterize drug products of all kinds at the AAPS PharmSci 360 event. Read more about our work here.

Learn about DigiM’s solutions for controlled released drug products at the 2020 CRS Annual Meeting.
At the CRS 2020 Annual meeting, DigiM presented our latest drug release simulations for PLGA microspheres, long-acting implants and more. Click here to learn more.

DigiM Receives FDA Contract to Study Microstructure Bioequivalence.
DigiM Awarded FDA Contract to Study Microstructure Bioequivalence of Polymer-based Long-acting Drugs (in collaboration with Dr. Diane Burgess’ Laboratory at UConn). Read the press release here. Medical News press release available here.

At the FDA regulatory science workshop, DigiM was invited to present our image characterization techniques!
DigiM’s Quantitative Image Characterization Featured in FDA regulatory science workshop on microstructure bioequivalence. Watch the presentation and read the press release here. AZO Materials press release available here.

Upcoming Events

Pharmaceutical

American Association of Pharmaceutical Scientists (AAPS) 2022 Annual Meeting and Exposition
Boston, Massachusetts -10/15-10/18

Seeing is Believing: A Microscopic “Google Earth” View of Extended-Release Claritin Formulation
Poster Number: T1530-06-34
Presented by Phil Yawman

Effect of Coacervation Processing Parameters on In vitro Drug Release from Minocycline Hydrochloride Microspheres
Poster Number: M0330-04-23
Presented by Ruifeng Wang at UCONN in collaboration with DigiM and FDA

Effect of Coacervation Processing Parameters on In vitro Drug Release from Minocycline Hydrochloride Microspheres
Poster Number: M1330-03-15
Presented by Yun-Chu Chen at Purdue University in collaboration with DigiM

Recent Presentations and Publications

Y. Pu, L. Ma, B. Dear, A. Zhu, J. Li, S. Zhang, W. Shi. Understanding the impact of microstructures on reconstitution and drying kinetics of lyophilized cake using X-ray Microscopy and image-based simulation. Journal of Pharmaceutical Sciences (2023). DOI.

Y. Suleiman, N. May, M. Zhang, A. Zhu, S. Zhang, J. McCutcheon, S. Shahbazmohamadi. In-situ 3D X-ray Tomography and Analysis of Reverse Osmosis Membranes Under Compaction. Microscopy and Microanalysis (28:S1) (2022) 270-271. DOI.

A. Clark, R. Wang, Y. Qin, Y. Wang, A. Zhu, J. Lomeo, Q. Bao, D. Burgess, J. Chen, B. Qin, Y. Zou, S. Zhang. Assessing microstructural critical quality attributes in PLGA microspheres by FIB-SEM analytics. Journal of Controlled Release (349: 7) (2022). DOI. With the FDA and UCONN.

W. Jia, P. Yawman, K.M. Pandya, K. Sluga, T. Ng, D. Kou, K. Nagapudi, P.E. Luner, A. Zhu, S. Zhang, H.H. Hou. Assessing the Interrelationship of Microstructure, Properties, Drug Release Performance, and Preparation Process for Amorphous Solid Dispersions Via Noninvasive Imaging Analytics and Material Characterization. Pharmaceutical Research (2022). Available online: DOI. With Genentech. Highlighted in Pharma Excipients article.

A. Zhu, C. Mao, P. E. Lunar, J. Lomeo, C. So, S. Marchal, S. Zhang. Investigation of Quantitative X-ray Microscopy for Assessment of API and Excipient Microstructure Evolution in Solid Dosage Processing, The American Association of Pharmaceutical Scientist PharmSciTech Journal (23:117) (2022). Available online. DOI. With Genentech.

T. Yeoh, L. Ma, A.Z. Badruddoza, J. Shah, S. Zhang. Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics, The American Association of Pharmaceutical Scientists Journal (24) (2022) p. 24-46. DOI. With Pfizer.

Y. Chen, D. Moseon, C. Richard, M. Swinney, S. Horava, K. Oucherif, A. Cox, E. Hawkins, Y. Li, D. DeNeve, J. Lomeo, A. Zhu, L. Lyle, E. Munson, L. Taylor, K. Park, Y. Yeo. Development of hot-melt extruded drug/polymer matrices for sustained delivery of meloxicam, Journal of Controlled Release (342) (2022) p. 189-200. DOI. With Eli Lilly.

S. Zhang, K. Nagapudi, M. Shen, J. Lomeo, Y. Qin, A. Zhu, P. Nayak, D. Chang, R. Hannoush. Release Mechanisms and Practical Percolation Threshold for Long-acting Biodegradable Implants: An Image to Simulation Study, Journal of Pharmaceutical Sciences (2021). DOI. With Genentech.

J. Gamble, M. Tobyn, S. Zhang, A. Zhu, J. Salplachta, J. Matula, T. Zikmund, J. Kaiser, P. Oberta. Characterization of the Morphological Nature of the Hollow Spray Dried Dispersion Particles Using X-ray Submicron-Computed Tomography, AAPS PharmSciTech (2021) 23-40. DOI. With BMS.

S. Zhang, P. Stroud, A. Zhu, M. Johnson, J. Lomeo, C. Burcham, J. Hinds, K. Blakely, M. Walworth. Characterizing the Impact of Spray Dried Particle Morphology on Tablet Dissolution Using Quantitative X-Ray Microscopy, European Journal of Pharmaceutical Sciences (165) (2021) 105921. DOI. With Eli Lilly

Z. Liu, L. Li, S. Zhang, J. Lomeo, A. Zhu, J. Chen, S. Barrett, A. Koynov, S. Forster, P. Wuelfing, W. Xu. Correlative Image-Based Release Prediction and 3D Microstructure Characterization for a Long Acting Parenteral Implant, Pharmaceutical Research (2021). DOI. With Merck.

S. Zhang, J. Lomeo. Cloud-based image management solutions for digital transformation of drug product development, Microscopy & Microanalysis 27 (S1) (2021) 296-297. DOI.

K. Nagapudi, A. Zhu, D. Chang, J. Lomeo, K. Rajagopal, R. Hannoush, S. Zhang. Microstructure, quality, and release performance characterization of long-acting polymer implant formulations with X-ray microscopy and quantitative AI analytics, Journal of Pharmaceutical Sciences. (2021). DOI. With Genentech.