Agenda March 16, 2027: Pre-Conference Workshop & PlenaryTuesday, 16 March 2027 - PT (Pacific Time, GMT-08:00)

Process modeling is becoming increasingly important in biopharmaceutical development, but its practical use should not be limited to modeling experts. This hands-on workshop demonstrates how scientists and process engineers can build, evaluate and maintain process models through an intuitive, guided modeling workflow. Starting from raw experimental data, participants will explore data from different sites, scales and process conditions and use it to develop models for upstream and downstream process optimization. The workshop follows the complete modeling lifecycle - from data preparation and model building to model evaluation, maintenance, versioning, traceability and regulatory-ready documentation. Particular attention will be given to making advanced modeling methods accessible to users without extensive statistical or programming expertise. Participants bringing their own laptop will have the opportunity to directly interact with the workflow and follow selected modeling steps themselves. No previous process-modeling experience is required.

Intensified upstream is now common, but fully connected end-to-end processes are still rare. The panel will look at what’s holding the industry back, starting with where the business case is strong and where cost-of-goods and footprint gains disappear, especially for retrofitted or multi-product facilities. Panelists will discuss how higher titers and continuous upstream move the bottleneck to capture, buffer management and viral clearance, and how to keep connected unit operations running at matching rates. They will also cover the real-time control and PAT that end-to-end processing needs, how far the ICH Q13 guidance on continuous manufacturing gets teams with regulators in practice, and the people and supply questions: training operators for weeks-long runs, validating scale-down models, and whether suppliers can support long continuous campaigns.

Process modeling is becoming increasingly important in biopharmaceutical development, but its practical use should not be limited to modeling experts. This hands-on workshop demonstrates how scientists and process engineers can build, evaluate and maintain process models through an intuitive, guided modeling workflow. Starting from raw experimental data, participants will explore data from different sites, scales and process conditions and use it to develop models for upstream and downstream process optimization. The workshop follows the complete modeling lifecycle - from data preparation and model building to model evaluation, maintenance, versioning, traceability and regulatory-ready documentation. Particular attention will be given to making advanced modeling methods accessible to users without extensive statistical or programming expertise. Participants bringing their own laptop will have the opportunity to directly interact with the workflow and follow selected modeling steps themselves. No previous process-modeling experience is required.