Baseline Scan

Quantify your drug product’s microstructure using samples or images to generate precise, data-driven maps before committing to costly scale-up and extended testing.

Who this is for

Formulation, process, and analytical teams that need a clear understanding of their product’s internal structure before making major development or scale-up decisions.

Ideal Timing

Baseline Scan is most valuable during scale-up, tech transfer, or clinical pinch-point decisions, when uncertainty around microstructure can introduce significant downstream risk.

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Business Outcomes

Early risk awareness

Identify microstructure-driven risks early, before committing to costly scale-up activities or long in vitro programs.

CQAs and benchmarks

Define a concrete set of CQAs and structural benchmarks that support development, tech transfer, and quality discussions.

Scientific Workflow

Provide us with representative samples or images. DigiM generates a quantified map linking microstructure to performance and scale-up risk.

Grayscale SEM cross-section of a tablet at 2 µm scale alongside a circular SEM image of microspheres at 100 µm scale

Data Acquistion

SDD morphology for thousands of particles

Pharmaceutical analysis infographic showing particle size distribution curves and microstructure characterization with API, pores, and polymer volume percentages

Analysis and Feature Extraction

critical quality attributes (CQAs) that matter for dissolution, stability, and tablet quality

Pharmaceutical particle identification image showing segmented API crystals within a tablet matrix

Structure-Performance Relationship

map CQAs to critical process parameters (CPPs) and manufacturing decisions

Applications

ASD XRM

Visualize and control amorphus solid dispersion particle microstructure to improve bioavailability, stability, and manufacturability at every stage of development.

MFV-SEM feature thumbnail showing multi-focus volumetric SEM imaging integration in the I2S platform

Implants

Streamline implant development with our quality by design approach. Use in silico predictions and microstructure insights for faster, cost-effective innovation.

Upscaled FIB-SEM image 4 of a pharmaceutical sample showing cross-sectional material phases at nanoscale resolution

Long Acting Injectable FIB-SEM

Focused Ion Beam Scanning Electron Microscopy is a technique for nanometer scale 3D imaging, typically targeting 3 to 50 nm resolution.

Pharmaceutical tablet microstructure image at 25 µm scale showing fine internal grain and phase boundaries

Oral Product mSEM

Transform oral product manufacturing with our approach, focusing on ingredient physicochemistry to minimize variability and enhance quality in scaled-up production.

True Density Measurement

Non-destructively measure internal density with digiM’s proprietary method, built to study batch uniformity and stability impact on product quality

Product X-Ray Microscopy

X-ray microscopy, in the family of X-ray micro-CT techniques, adds local tomography capabilities to zoom into a small area within a larger sample.

Upscaled SEM image 1 of a spray dried dispersion showing high-resolution particle morphology and surface texture

Transform Your Program with Microstructure Science

Get started with a drug product digital twin.

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Purple tablet dispersing into a fine particle cloud, illustrating drug microstructure disintegration