The Journey Of Implementing Advanced Process Control In the Pharmaceutical Industry

02nd March 2020 | 10:00 am EST | Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology Center of Excellence, Technical Operations, Janssen Pharmaceuticals |BOOK FREE SEAT

The presentation will share 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 designs, 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.

APC 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 APC can bring about significant reductions in process deviations and impact the right first time metric. Additionally, it is possible to improve process performance such as cost and cycle time modestly in exciting filed processes. We will highlight areas where APC is being used in an open loop manner and with human oversight. In these applications there is much value to a manufacturing organization in enabling smoother processes operations and helping the operators making sense of complex process data and potential undesired outcomes.

The journey Janssen is taking is one that started by demonstrating the value of modeling, APC and digital twins during the construction of a new oral solid dosage form facility in Xian China. From there it progressed with our project Prometheus to use PLS/PCA type approaches for process monitoring of existing processes. Lately the APC applications have begun incorporating more quality relevant process analytical technology data such a Raman spectroscopy for bioreactor performance as an example. It is envisioned that this long term will help to provide real time quality awareness and real time release for certain drug substance products in large and small molecule API and DP.

In conclusion, Janssen is seeking to enable its core organizational goals using a set of technology tools, one of these being APC.  APC is evolving into mission critical enabling technology not just for real time quality and real time release but as the enabler for the two other technology pillars of flexible and modular manufacturing and highly intensified processes.

Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology Center of Excellence, Technical Operations, Janssen Pharmaceuticals

Olav is a Sr. Scientific Fellow and group leader within Technical Operations, Janssen Supply Chain. The last 6 years with Janssen he has been leading a team delivering mechanistic modeling, process analytical technology and advanced analytics solutions for large and small molecule active pharmaceutical ingredients and drug product processes.

Olav holds a Ph.D. in Chemical Engineering from the University of Minnesota where he studied under Professors Scriven and Flickinger. He holds a Master of Science degree in Chemical Engineering from The Technical University of Denmark where he studied with Prof. Jens Nielsen.

Olav started his industrial career in Chemical Development with Bristol-Myers Squibb in 2000. During his tenure with Bristol-Myers Squibb he among other things pioneered the use of mechanistic and engineering-based modeling for small molecule active pharmaceutical ingredient process development. He also led an effort to develop and implement a rigorous FMEA based process risk assessment approach and he served as the CMC lead for several neuroscience drug candidates.

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