Value through Innovation16 January 2013
Process Development for Formulations
Our centre of excellence for formulation process development services is located in Columbus, OH.
Our portfolio
Center of Excellence in Columbus, OH for process development for formulations
- Optimization of solid and liquid dosage form delivery systems utilizing Process Analytical Technology (PAT) and Quality-by-Design (QbD) toolbox
- Pilot through commercial scale equipment
- Production according to current Good Manufacturing Practice (cGMP)
- Professional project management with dedicated project manager
- Integrated services on site in Columbus including Quality Control (QC) and regulatory experts
- State-of-the-art analytical equipment for analytical method development
- Comprehensive services in support of regulatory filing, e.g. quality risk analysis (QRA), proven acceptable ranges report, P documents
- Multi-dose and unit dose packaging available (primary and secondary)
Our special areas of expertise
- Potent Compound capabilities (OEL > 0.1 microgram/m³)
- Columbus site DEA approved for manufacture, storage and shipment of scheduled drugs
- Broad technology range of solid tableting: direct compression, wet & dry granulation, film & tablet printing , encapsulation
- Primary and secondary packaging services including bottles, closures, blisters and pouches
- Nasal suspensions
- Pediatric Formulations
