A customized and fit-for-purpose particle engineering service as part of our integrated drug substance and drug product offering. You can access:
Each offering is in place to help advance your compound from concept to clinical and commercialization.
Particle size reduction to precise particle size distribution is in place for API milling across pin mill, hammer mill, jet mill and nano-mill processing at our Monteggio (CH) site.
Particle engineering services using spray drying, hot-melt extrusion, or melt-spray-congealing are located at our Bend (US) site.
Particle size reduction via micronization or nano-milling and amorphous solid dispersion technology, via hot-melt extrusion or spray drying are often utilized to improve stability, flowability, dissolution rate and solubility.
We will help you develop your technology selection methodologies to incorporate models and reference maps over key formulation parameters. Advance your molecules across API parameters, applications and target product profiles.
We have experience in proprietary lab-scale processing that requires minimal amounts of API for feasibility assessments. Our product development teams utilize these tools to rapidly select and employ the best particle engineering approach to address the problem statement(s) and meet your target product profile in a phase-appropriate manner.
We have invested in specialized particle engineering processing to ensure that the needs of any compound can be addressed.
High containment capabilities are in place so that mechanical, jet milling and spray drying can be safely conducted with highly potent API or cytotoxics. Before processing, every drug substance is evaluated by our Health, Safety & Environment (HS&E) team to determine the containment system required.
Specialized cryogenic API milling is also in place for those friable compounds needing cooling due to low melting points or to avoid polymorphism.