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

Overview:

Since 2002, the FDA has promoted a continuous, process-centric approach to validation vs. the prior product–centric one. Yet, many pharma and biopharma companies have failed to incorporate that approach into their strategic plan. This white paper explains the new distinctions and what they mean in practice, then identifies PAT opportunities that can be implemented immediately to support QBD activities.