Full Title: The Journey Of Implementing Advanced Process Control In the Pharmaceutical Industry Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen Pharmaceuticals The presentation shared the journey that Janssen is taking as it progresses its strategy on Advanced Process Control (APC). Within Janssen we aspire to improve our Manufacturing Technology Organization’s performance on key metrics such as cost of goods, on time and in full product delivery, production cycle time, and right first-time process performance. Improving these metrics require a comprehensive technology strategy that can address not just one but all the key metrics together. The strategy that Janssen is pursuing has three pillars. 1: Process Intensification, 2: Modular and Flexible manufacturing, and 3: Process Digitalization and Advanced Process Control. Each pillar contributes differently to the key metrics and in aggregate and when achieved together they make it possible to reach all the goals. Advanced Process Control is a critical component of the technology strategy in that it is an enabler for Process Intensification and Modular and Flexible Designs. As a stand-alone tool Advanced Process Control can bring about significant reductions in process deviations and therefore also impact the right first time metric. It is also possible to improve process performance such as cost and cycle time modestly through APC. We highlighted areas where APC was being used in an open loop manner and with human oversight. In these applications there is still much value to a manufacturing organization in enabling smoother processes operations and helping the operators making sense of complex process data and quickly alert them to potential undesired outcomes.


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