Pharma Industry Still Not At 'Tipping Point' In Adopting Continuous Manufacturing
Regulators and industry officials agree that despite efforts to spur development of continuous manufacturing, uptake has been slow globally. FDA still is on learning curve and acknowledges a knowledge gap around some of the higher order principles associated with continuous manufacturing.
You may also be interested in...
Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’
The oncology branch of the US FDA’s biologics center does not believe RTOR would speed application reviews.
A recent survey shows that pharmaceutical manufacturers are increasingly interested in adopting continuous manufacturing. Most respondents say they plan to use this mode of manufacturing for their new drugs.