From Candidate Drug Selection to Manufacturing
The solid state development leads your compound from initial candidate selection via crystallization process development to drug formulation; to optimize solubility, stability and bioavailability. The unique workflow combines Design of Experiments (DoE) with Principle Component Analysis (PCA) for rapid evaluation of product characteristics and the inherent design space that controls them. This helps obtain a broad overview to characterize your product while affording critical data to support design of the ultimate manufacturing process.
Alcami fields this preformulation capability through its API development and manufacturing facility in Germantown, WI.
- Crystallization Study – crystallize to obtain stable solids, for purification or isolation
- Material Characterization – polymorph identification
- Solubility Determination – in production solvents and buffer solutions
- Salt Selection – suitable form selection
- Polymorph Study – behavior in production solvents
- Crystallization Process Development – combine optimal synthesis conditions with optimal crystallization conditions
- Crystal Habit Optimization – control of particle size and shape
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