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Solid State Development
The solid form taken forward is difficult to change later, and it sets the stability profile and part of the patent position.
Why the form matters
Solid-state properties significantly affect the pharmaceutical performance of an oral solid drug. A thorough characterization of the solid-state behavior of both API and drug product is needed at every stage of development.
We run salt, co-crystal and polymorph screening for toxicology and clinical development, and the full polymorph study an NDA filing needs. That includes crystal structure analysis, solid form quantitative methods, and simulation and modeling where experiment alone is inconclusive.
The team and the throughput
- 90+ scientists
- 400+ solid form screening projects a year
- 85,000+ characterization tests a year across all development stages
- 1,000+ m² of laboratory space
- 30+ advanced instruments
High potency compounds are supported at an occupational exposure limit of 10 ng/m³.
Solid state chemistry
- Salt, co-crystal and polymorph screening for tox and clinical development
- Comprehensive polymorph study for NDA filing
- Salt and polymorph study for technical lifecycle management
- Solid state characterization
- Solid form quantitative analysis
- Crystal structure analysis
- Simulation and modeling
- Troubleshooting
Powder characterization
- Flowability, particle size, morphology, surface area, and density.
Material science
SEM-EDS, micro-CT, Raman, wettability, and texture analysis — the techniques that explain why a powder will not compress.
Instruments
- XRPD, VT- and VH-XRPD, capillary XRPD
- DSC and mDSC, TGA, DVS (GVS)
- PLM with a thermal stage, stereo microscope
- Confocal Raman, confocal IR, FT-IR, ss-NMR
- SEM-EDS, XRM (micro-CT), micro-ED
- Particle size analyzer, specific surface area
- True density, ribbon density and tapped density testers
- Powder flow analyzer (FT4), texture analyzer, contact angle analyzer
Across the whole development cycle
The same team supports drug substance and drug product through discovery, preclinical, Phase I, Phase II, Phase III, and commercial.