With expertise in characterizing and modifying a drug substance’s physical, chemical and mechanical properties, our objective is to help you assess and choose the best solid form for progression into animal and human dosing trials. We also provide early formulation design and development data, solid state analysis, and crystallization process development and troubleshooting. Access stand-alone services or pursue an integrated solution with our expert discovery, development and manufacturing capabilities.
AMRI has the experience and technology to solve your most complex solid form and production-related problems. Whether it is particulate or impurity identification, batch variation, poor recovery, physical property differences, failure to meet specifications or stability issues, our experts identify and customize the appropriate course of action to achieve effective, efficient solutions.
We have produced critical scientific data on drug substances at stages ranging from preclinical studies, clinical dosing and commercial.
Our complete suite of services includes:
- Comprehensive solid state characterization and ongoing support
- Systematic solubility enhancement for improved dosing performance
- Systematic salt screen and ongoing support for selection
- Comprehensive cocrystal screen and ongoing support for selection
- Preliminary and exhaustive (intellectual-property-focused) polymorph screening and ongoing support
- Crystallization process troubleshooting and optimization with PAT capabilities
- Early formulation composition design and development, including compatibility, stability and degradation mechanism elucidation
- Manufacture of GLP supplies
- Chiral resolution screening
- Particle size reduction and characterization
- Physical form stability and quantitation
- Structural elucidation
- Foreign particulate identification
- Spray drying process development
- Amorphous stabilization