Research Scope & Focus Scope Development and manufacture of API, formulations and delivery systems Process for development and manufacturing of pharmaceuticals Key research topics • Process design, development & prediction of product performance, quality and safety from early parameters • Quality by Design • General process design tools that allow integrated design of processes • Issues with Scale-up of Batch Processes • Miscellaneous
Research Initiatives Cooperative R&D Agreement (CRADA) NIPTE, Industry, FDA Multi-Client Research Narrowly defined, separately contracted Proprietary Research Exclusive & privately funded research FDA-Specific Research Focused consortia Projects CAMP, API-PTCC, CPPR, etc NSF, NIH Grant Programs
