A key focus area currently is the application of modelling and digital design for manufacturing process design and development. An exciting frontier in process simulation is the development of systems models, which are integrated models for pharmaceutical processes encompassing multiple unit operations. These models allow a systems-wise assessment of process parameter impact across a sequence of unit operations. While in GSK, the interest in systems modelling started with the advent of continuous manufacturing, more recently, we have expanded the scope of systems modelling to include batch manufacturing processes across small and large molecule drug substance and product.

In this webinar, we will share our emerging knowledge and insight into the development of systems modelling with representative case studies, and potential benefits of such approaches aligned with QbD development principles. In addition, we will share our reflection on regulatory considerations as related to the positioning of systems modelling in files. This webinar will be in the format of brief presentations followed by a panel discussion.

Learning Objectives:

• Understanding of the concept of systems modelling
• Potential application of systems modelling in pharmaceutical development (including but not limited to sensitivity analysis & parameter criticality evaluation in QbD risk assessment, simulated experiments, whole plant analysis and optimization)
• Regulatory considerations for building systems models, in particular the category of model impact
  

Sayantan Chattoraj, Ph.D.

Dr. Sayantan Chattoraj is a pharmaceutical product development leader with 12 years of industry experience in the design and development of drug products across small and large molecules from early to late-stage development & commercialization, including the development of GSK’s first commercialized drug product based on continuous manufacturing. He has done his Ph.D. from University of Minnesota with specialization in Pharmaceutical Materials Science and Solid-State Pharmaceutics. He is passionate about integrating pre-formulation & formulation development, materials science, modelling, and biopharmaceutics to guide product design and development. He currently leads the Process Analytics team at GSK across small and large molecule drug substance and drug product in the US.

Tony Colarusso

Tony Colarusso is a Senior Scientist in the Process Engineering & Analytics group at GSK. After graduating from Villanova University with a degree in chemical engineering, Tony began his career with GSK working in bioreactor process development and scale-up. In his current role, Tony supports data-driven modeling for commercial-scale bioreactor process monitoring and mechanistic modeling efforts for large molecule drug substance manufacturing.

Helen Yao, Ph.D.

Dr. Helen Yao is a Principal Investigator at GSK in the Process Engineering and Analytics (PE&A) team, where she develops computational models to support small and large molecule drug substance and drug product development. Dr. Yao completed her B.S.E. in Chemical and Biological Engineering in 2015 at Princeton University. In 2020, she received her Ph.D. in Chemical Engineering at Massachusetts Institute of Technology in the lab of Prof. Bradley Olsen, where she studied self-assembly of protein-polymer bioconjugates using scattering and molecular dynamics simulation. At GSK, Dr. Yao’s research focus is mechanistic, data-driven, and hybrid process model development and deployment to accelerate drug delivery to patients. In addition to her scientific work, she is passionate about STEM outreach and has organized events for the PE&A team at local Philly high schools.