The Journey Of Implementing Advanced Process Control In the Pharmaceutical...

Presented by

Olav Lyngberg, Sr Scientific Fellow at Janssen Pharma and Mark Demesmaeker Head of Data Analytics at Sartorius Stedim Biotech

About this talk

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 and 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. Followed by Obtaining Increased Observability & Control of the Bioprocess Presented by Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech As the biopharmaceutical industry is undergoing the digital transformation, a number of disruptive technology evolutions and market shifts are happening in parallel: Novel approaches in bioprocessing (e.g., intensified and continuous processing) are pushing cells and expression systems to their limits. New process analytical technologies are introduced, including online spectroscopy, advanced single-use sensors, and advanced modeling and simulations. Adding to that a trend towards increased miniaturization and throughput of cell culture processes puts an enormous burden on data streaming, management, and preparation. Recent progress in cellular and gene therapies also contributes to the evolution of bioprocessing.

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