By Stefan Hyde, Automation Manager, Asahi Kasei Bioprocess America
The pharmaceutical industry is struggling with the exponentially growing demand for Oligo drug substance – and as the race to keep up continues, adding/onboarding knowledgeable resources becomes increasingly difficult. This means that the solution to the supply problem may very well require an evolution of the industry’s manufacturing facilities to employ Pharma 4.0™ concepts to support not only the growth of the workforce but also increased per-head productivity. New digital technologies must be implemented to reduce testing and installation time, ease training for new operators and scientists, streamline production, and deliver real-time batch results for clearance and approval.
Here we will explore what Pharm 4.0 is, the ICH Q10 model, and the benefits of digitalization.