As Continuous Manufacturing Approaches 'Tipping Point,' Successful Applicants Share Tips
Executive SummaryThe pharmaceutical industry may be approaching a "tipping point" with applications for continuous manufacturing, and successful applicants share secrets to the success they have achieved with FDA and other regulatory authorities around the world.
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FDA is hoping that by laying out its expectations for continuous manufacturing, applicants will feel more comfortable about adopting such approaches instead of sticking with conventional batch methods.
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.
As pharmaceutical companies begin taking advantage of continuous manufacturing, they are realizing how it can transform an industry rooted in batch processing. Now they have drafted a survival guide.