Strategic Partnerships

The New Biopharmaceutical Blueprint

This paper by IBM explores how service-oriented architecture can help enterprises effectively achieve business flexibility within a compliance environment.

Kick-Starting PAT to Achieve Quality by Design in cGMP Bioprocessing

Since 2002, the FDA has promoted a continuous, process-centric approach to validation vs. the prior product-centric one. This white paper explains the new distinctions and what they mean in practice, and then identifies PAT opportunities that can be implemented immediately to support QBD activities.