BIOPHARMACEUTICAL PROCESS MODEL EVOLUTION - ENABLING PROCESS KNOWLEDGE & ADVANCED PROCESS CONTROL

Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen, followed by David Lovett, Managing Director at Perceptive Engineering & John Mack, Engineering Director at Perceptive Engineering
Biogen is adopting modelling maturity models similar to the ones used by high-tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial, particularly when implementing data-driven models that rely on process experience. A well-planned modelling continuum should allow the pharmaceutical industry to realize the benefits of modelling activities early on while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).