DigiM Solution provides drug product development support using microstructure contract research organization (CRO) services and software solutions, focusing on applications such as microspheres, lyophilization, tablets, implants, and more.

DigiM Solution

Pharmaceutical Manufacturing

digiM Bioequivalence Solutions

digiM | 1,067 followers on LinkedIn. Empowering drug product development with end-to-end microstructure CRO and software solutions | Transforming drug product development with the combined power of advanced microscopy, AI analytics, and in silico dissolution. We support the development of innovator and generic therapeutic programs.

Aiden Zhu

Strategic Digital Marketer: Driving exponential growth in organic traffic.

Jeannie Dougherty

Software Development Manager at DigiM Solution

Sam L.

Sr. Director of Business Development at DigiM Solution

Itay Speicher

digiM

💊 📰 🔬 Big news from digiM! The FDA has purchased a subscription to the I2S cloud platform for image analytics and data management. Joshua Lomeo , digiM's Application Science Director, spoke on the license agreement: "Use of AI and cloud-based technologies comes with great responsibility in maintaining data integrity and security, and we feel privileged that the FDA has entrusted us with this. I2S is built from the ground up with the best principles in data accessibility and tracking in mind, including audit capabilities for FDA 21 CFR Part 11 Compliance. We are honored to support their work reviewing life-changing therapeutics." More info below! #drugdevelopment #drugspharmaceuticals #ai #imageprocessing #regulatory #fda #imageanalysis

Our eagerly anticipated paper on in silico formulation development has been published in Springer Nature ! The paper presents a new Generative AI methodology for structural synthesis from microscopic images. The technique uses AI to modify properties like particle size and drug load in a 3D image of a drug product. The result is a new digital formulation, where the impact of microstructure changes on drug release can be systematically and digitally predicted. A big thanks to our collaborators Chen Mao , Athanas Koynov , Prajwal Thool , Karthik Salish , Morgan Giles , and Karthik Nagapudi . The use of real world drug products and the considerations towards development were invaluable in developing and demonstrating this technology. The paper is open access and available for all to view. If you are interested to learn more, keep an eye out for our upcoming webinars! https://lnkd.in/e848K-hJ

📰 💊 🔬 We are thrilled to share a new contract from the FDA to support the development and regulatory assessment of complex drug products. Through this IDIQ, detailed assessments of RLD products and in house formulations will be performed. Findings will support the agency's considerations for product specific guidelines while bolstering industry knowledge on these products. The priority products selected for microstructure studies include: - Ozurdex dexamethasone intravitreal implant - Perseris risperidone extended-release injectable suspension - Mirena levonorgestrel-releasing intrauterine system - Eligard leuprolide acetate injectable suspension - Liletta levonorgestrel-releasing intrauterine system - Bydureon BCise exenatide extended-release injectable suspension https://lnkd.in/ejHvCR5P

Happy halloween! This Jack-o-lantern is a co-processed particle of drug crystals and polymer. Working with our collaborator Deniz Erdemir from Bristol Myers Squibb , we applied FIB-SEM to get a cross-sectional look inside these particles. Deniz discovered the happy pumpkin, "It looked exactly like a jack-o-lantern, I felt like there was a surprise hidden inside. I smiled like a kid on Halloween with a bucket full of candy.” Co-processing is an important technique to improve the manufacturability of certian drug substances, such as blending, sticking, and compaction. With FIB-SEM analysis, extra insight into the size of the API particles and their interaction behavior with the polymer was gained, providing important considerations for future process development. Happy halloween, and may your formulation development be full of sweet surpises! 🍭🍬 🎃

A few microsopic snapshots in time of a wonderful week at AAPS! Thanks again to everyone who stopped at our booth and viewed our posters. Events like PharmSci360 are the best opportunity to discuss challenges in drug development and work together in bringing new solutions for better product quality and program success. A big thanks to all of our clients and poster collaborators!

In just a few days we will be at the annual PODD: Partnership Opportunities in Drug Delivery Community News meeting! We look forward to seeing old friends and new faces a like. If you're attending, be sure to check out Dr. Andrew Clark's talk on the behavior of PLGA microsphere systems. Want to chat with us at the show? Reach out to Itay Speicher and find a time to meet. #PODD2024 #DrugDelivery #DrugDevelopment

AAPS #pharmsci360 is officially live! Our team is thrilled to be in Salt Lake, and looking forward to exciting discussions with our collaborators and friends, plus an excellent set of sessions and posters to attend! Join us at booth #2538 and learn how imaging will change the way you think about your drug product!

Next week at #pharmsci360 , we are thrilled to share some of our latest solutions for drug delivery and product optimization. From dissolution exposure studies, ex vivo vs in vitro analysis of long-acting products, and digital formulation development, the application of image-based studies for drug product development are ever growing. Look forward to seeing all our friends and collaborators next week!

Looking ahead to AAPS next week, we are excited to share a preview of a talk by our collaborator Tatiana Marcozzi ! The project, in collaboration with Tatiana and Sune Klint Andersen from Johnson & Johnson Innovative Medicine , demonstrates how enhanced imaging resolution and quality from synchrotron X-ray micro-CT systems was used to study complex spray dried dispersion morphologies. Analysis of synchrotron data was able to differentiate particle populations based on presence vs absence of voids, as well measurements of internal vs external surface areas. These parameters are critical to the processability and performance of the particles in downstream processing. The analysis was connected with the corresponding process parameters to support navigation of decision making in a complex design space. Tatiana's talk will take place on Wednesday the 23rd from 10-10:30 in room 155E. We look forward to seeing you there! #pharmsci360 American Association of Pharmaceutical Scientists (AAPS) | @aapscomms #aaps

At the upcoming #pharmsci360 , our own Andrew Clark will give a rapid fire talk sharing perspectives on how synchrotron micro-CT analysis is guiding drug development decisions! Andrew will share a series of use cases where this analysis has proved transformative in drug product understanding. Amongst these is a study on excipient behaviors, in collaboration with our partners Chen Mao , Prajwal Thool , and Karthik Salish . With non-invasiveness and highest resolution capabilities, synchrotron allows us to visualize tablet disintegration phenomena. After hydration, the formation of an expanded pore network and clarity on the size of disintegrating components can be obtained. With this method, the impact of functional and non-functional excipients on disintegration time and dissolution performance can mechanistically understood, better informing ultimate formulation decisions. We look forward to see our partners and friends at American Association of Pharmaceutical Scientists (AAPS) | @aapscomms ! Keep an eye out for the next two talk previews!

DigiM Solution provides drug product development and microstructure contract research organization (CRO) services, along with software solutions.

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