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

Check out our presentations at the 2021 AAPS PharmSci 360 conference! We will also be there physically in Philadelphia, PA, come meet us at exhibit booth #209.
Most recently at 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) 2021 PharmSci 360
Philadelphia, PA – October 17th to October 20th
Exhibit Booth #209
1. Symposium: Long-Acting Drug Delivery System Development and Evaluation.
  Mechanistic Evaluation and T0 Image-based Release Prediction for Long-acting Delivery.
  Tuesday, October 19, 2021, 10:00 AM – 10:30 AM ET, Location: 113 ABC, Pennsylvania Convention Center.
  Also available as an On Demand Talk.
2. Development of Hot-Melt Extruded Polymer Matrix for Sustained Delivery of Meloxicam. In collaboration with Purdue University.
  Monday, October 18, 2021, 9:30 AM – 10:30 AM ET
3. Effect of Coacervation Processing Parameters on Drug Release from Minocycline Hydrochloride Microspheres. In collaboration with FDA and UCONN.
  Tuesday, October 19, 2021, 10:30 AM – 11:30 AM ET. Location: Virtual.
4. PLGA Microsphere Formulation Development Guided by Microstructure Equivalence Assessment Using FIB-SEM Imaging and AI Image Analytics. In collaboration with FDA and UCONN.
  Monday, October 18, 2021, 3:30 PM – 4:30 PM ET

American Institute of Chemical Engineers (AIChE) 2021 Annual Meeting
Boston, MA – November 7th to November 11th

Recent Presentations and Publications

Press Release and News

Meet us at 2021 AAPS PharmSci 360!
Check out our presentations at the 2021 AAPS PharmSci 360 conference! We will also be there physically in Philadelphia, PA, drop by at exhibit booth #209 to discuss your microstructural challenges.

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) 2021 PharmSci 360
Philadelphia, PA – October 17th to October 20th. Exhibit Booth #209.
Check out our presentations below! More information here.

Symposium: Long-Acting Drug Delivery System Development and Evaluation.
Mechanistic Evaluation and T0 Image-based Release Prediction for Long-acting Delivery.
Tuesday, October 19, 2021, 10:00 AM – 10:30 AM ET, Location: 113 ABC, Pennsylvania Convention Center. Also available as an On Demand Talk.

Development of Hot-Melt Extruded Polymer Matrix for Sustained Delivery of Meloxicam. In collaboration with Purdue University.
Monday, October 18, 2021, 9:30 AM – 10:30 AM ET

Effect of Coacervation Processing Parameters on Drug Release from Minocycline Hydrochloride Microspheres. In collaboration with FDA and UCONN.
Tuesday, October 19, 2021, 10:30 AM – 11:30 AM ET. Location: Virtual.

PLGA Microsphere Formulation Development Guided by Microstructure Equivalence Assessment Using FIB-SEM Imaging and AI Image Analytics. In collaboration with FDA and UCONN.
Monday, October 18, 2021, 3:30 PM – 4:30 PM ET

American Institute of Chemical Engineers (AIChE) 2021 Annual Meeting
Boston, MA – November 7th to November 11th. Exhibit Booth #401.

Recent Presentations and Publications

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

S. Horava, J. Lomeo, M. Shen, R. Ayyar, K. Eddy, S. Zhang, M. Swinney. Evaluating API Release Performance from Controlled Release Polymer Matrices with Microstructure Imaging and Image-based Prediction Models, Talk presented at CRS 2021 Virtual Annual Meeting, 2021 Jul 25-29; Virtual. Eli Lilly talk featuring DigiM’s analysis.

I. Terzic, M. Staal, A. Doornbos, I. Kok, K. Staal, J. Visscher, A. Funhoff, T. Nguyen, W. Vos, P. V. Midwoud, R. Steendam. Next generation bioresorbable contraceptive implants, Talk presented at CRS 2021 Virtual Annual Meeting, 2021 Jul 25-29; Virtual. Innocore talk featuring DigiM’s analysis.

M. Shen, Y. Wang, S. Zhang, B. Qin, Q. Bao, D. Burgess. Characterization of the Stability of PLGA Microspheres Using Image-based Key Performance Attributes and Release Prediction, Poster presented at CRS 2021 Virtual Annual Meeting, 2021 Jul 25-29; Virtual.

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.

Xi, H., Zhu, A., Klinzing, G.R., Zhou, L., Zhang, S., Gmitter, A.J., Ploeger, K., Sundararajan, P., Mahjour, M., Xi, W. (2020). Characterization of Spray Dried Particles Through Microstructural Imaging. Journal of Pharmaceutical Sciences.August 2020. With Merck. More details here.

Wu, D., Zhou, L., Zhang, S. (2020). Characterization of Controlled Release Microspheres Using FIB-SEM and Image-Based Release Prediction. AAPS PharmSciTech. July 2020. With Bausch Health.

Zhang, S., Nagapudi, K. (2020). Micro-imaging Based Characterization and Release Prediction of a Long-Acting PLGA Implant. Poster presented at the Long-Acting Injectables and Implantables meeting in La Jolla, CA. With Genentech.

Zhang, S., Goldman, J., Chen, X., Rowe, J., Lin, S., Zhou, L. (2020). Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics. Drug Development & Delivery.

Howard, J. (2019). Machine-Learning Methods in Image Processing and Analysis of Porous Materials. DigiM whitepaper.

Zhou, L., Stroud, P., Zhu, A., Hinds, J., Blakely, K., Zhang, S. (2019). Characterization of Spray-Dried Aggregates for Tablet Formulation with Microstructure 3D Imaging Analytics. Poster presented at 2019 AAPS PharmSci 360 in San Antonio, Texas. With Eli Lilly.

Zhu, L., Yin, D., Qin, Y., Konda, S., Zhang, S., Zhu, A., . . . Lin, H. (2019). Sorption‐Enhanced Mixed Matrix Membranes with Facilitated Hydrogen Transport for Hydrogen Purification and CO2 Capture. Advanced Functional Materials.

Howard, J., Lin, S., & Zhang, S. (2019). Uncertainty Quantification in Image Segmentation for Image-Based Rock Physics in a Shaly Sandstone. Petrophysics,60(2), 240-254.