digiM Solution Partners with CMAC to Revolutionize Digital CMC Processes

Microstructure CQAs
Tablet
September 2, 2024
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# Minute Read

digiM Solution is the most recent organization to form a dynamic partnership with CMAC as a Tier 2 member, joining CMAC’s cutting-edge technology portfolio. Together, CMAC and digiM will align to accelerate research and development within CMAC’s ambitious strategy for digital transformation of Chemistry, Manufacturing, and Control (CMC) processes.

Working together, CMAC and digiM will accelerate advanced understanding of drug product manufacturing, performance, and stability through quantitative analysis of cutting-edge X-ray computed tomography and other image-based data.

CMAC will utilize the digiM Image 2 Simulation (I2S) cloud software to enable the analysis of imaging data collected within its world-class facilities. This combined approach will assist pharmaceutical researchers with the quantification of advanced microstructure properties pertinent to optimizing the performance and manufacturability of pharmaceutical materials. This includes morphology and structure properties such as internal particle size, porosity, surface area, coating thickness, and mass transport simulations that enable dissolution predictions.

The collaborative efforts of CMAC and digiM Solution will encompass further joint research initiatives and knowledge exchange, including support towards the cutting-edge research in CMAC’s DataFactory program, alongside the industrial applications that will seek to drive the adoption of digital solutions in medicines development and manufacturing.

About CMAC

CMAC is an internationally leading medicines manufacturing research center with a unique configuration of academic research, applied and pre-competitive programs. Working in partnership with large pharma, technology providers, academic and innovation partners, CMAC's goal is to transform Medicines Development, Manufacture & Supply and further grow its pipeline of world-class multi-disciplinary collaborative research.

The center's portfolio currently includes the Made Smarter Innovation: Digital Medicines Manufacturing Research Centre (DM²), EPSRC international Digital Design and Manufacture of Amorphous Pharmaceuticals (DDMAP) collaboration, UKRPIF supported Net Zero Pilot and CMAC Data Lab, EPSRC CDT Cyber-physical Systems for Medicines Manufacturing (CEDAR), and the EPSRC MediForge Hub, along with training and translation projects within a world-class facility.

For more information on CMAC visit: https://cmac.ac.uk/

About digiM Solution

digiM is a technology provider that supports drug product development with end-to-end microstructure CRO and software solutions. digiM’s I2S cloud software integrates AI image processing, microstructural analysis, digital formulation, image-based simulation, and data management to support the lifecycle of advanced microscopy data analysis. I2S modules are custom built to address the most critical questions and attributes of pharmaceutical materials. Through integration of microscopy based digital twins and in silico modelling, the digiM platform provides a full spectrum understanding of drug product properties and performance.

digiM works closely with leading innovators and generic developers to navigate development challenges, having supported over 100 pharmaceutical partners, 200 therapeutic programs, and 1,600 drug intermediates and products. digiM works closely with regulatory bodies, including the FDA, paving an advanced understanding for the role microstructures play in product quality, while also bridging the gap between industry and agencies.

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