White Paper: Kick-Starting PAT To Achieve Quality By Design In cGMP Bioprocessing

John Walker, TechniKrom Inc.

In 2002 the FDA announced a revolution in how they intended to regulate drug manufacturing. Their initiative promoted a continuous, process-centric approach to validation to replace the current product-centric one. Now known as Quality by Design (QBD) it incorporates, among other initiatives, process analytical technology (PAT) as a key tool for designing and optimizing manufacturing processes. Furthermore, the FDA took clear aim at eliminating the stagnation in the adoption of new manufacturing technology that their previous approach had encouraged. Many companies still have been unable or unwilling to seize this initiative and turn it into a key element of their strategic plan. Part 1 of theis white paper explores and clarifies the new distinctions and exactly what they mean in practice. In the Part 2 some ‘low-hanging fruit' PAT opportunities are identified that can be immediately implemented in order to ensure a successful and profitable kick-start to QBD activities.