The Journey Of Implementing Advanced Process Control In the Pharmaceutical Industry


16th March 2020 | 10:00 am EST | Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology Center of Excellence, Technical Operations, Janssen Pharmaceuticals and Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech |WATCH FOR FREE

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.

 

Followed by Obtaining Increased Observability & Control of the Bioprocess

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. The challenge and opportunity for “bioprocessing 4.0” is to respond to the shifting market demands, leveraging technology options for connected systems, process automation and monitoring, and model-predictive control.

The main benefits of model predictive control in bioprocessing are an increased observability of the process, paired with the resulting improvements in process robustness:

  • Shortened process development cycles and accelerated time to market (e.g., through data-driven cell-line development and media screening, robust scale-down models and scale-conversion tools, etc.)
  • Increased product titers and yields (through enhanced observability of cell states and metabolic trajectories)
  • Improved downstream process efficiency (supported by kinetic models that save on buffers and resins)
  • Enhanced product quality and similarity (through, for example, influencing glycosylation patterns by model-controlled feeds)

 

Presented by Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech

Dr. Mark Demesmaeker is Head of Data Analytics, Sartorius Stedim Data Analytics (SSDA), part of Sartorius-Stedim Biotech. Mark joined SSDA in 2018. He is a life science professional with over 20 years of experience in pharmaceutical R&D, analytics and business intelligence, and has held leadership positions at the World Health Organization, Spotfire, TIBCO Software, IBM, and Integrated Clinical Systems. Most recently, he served as Vice President, Clinical & Translational Analytics at PerkinElmer Informatics. Mark holds a Ph.D. in drug metabolism and pharmacokinetics from the German University of Kiel.

Sponsored by Sartorius Stedim Data Analytics

Sartorius Stedim Data Analytics develops software under the Umetrics Suite for design of experiments and multivariate data analysis, for the individual user as well as for on-line continuous and batch processes.
The stability of Umetrics founding principles and the flexibility of our services enables us to promote every way of implementation of design of experiments and multivariate technology that our clients require. We are committed to supporting our clients in their mission to take control over their data flow, by conveying our advanced expertise in advanced data analytics technology. Our mission is to provide comprehensive solutions which create value from data, enabling better decision making and process excellence.

Our market exists in every sector of industry where there are manufacturing, testing or data analysis activities, but historically the highest number of collaborations has been in the life science, semiconductor and chemical industries. Umetrics is since April 2017 owned by Sartorius Stedim Biotech AS.


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