Process-as-Product Paradigm

Overview

The cell and gene therapy industry axiom 'the process is the product,' critiqued by Matthew Dy as historically encoding ignorance rather than discipline, and reframed as a mandate for deep process characterization that enables continuous platform improvement and regulatory knowledge reuse. The cell and gene therapy axiom 'the process is the product' originally encoded a lack of process understanding: manufacturers could characterize neither the process nor the end product, leading to a blanket prohibition on any process change — a stance that Matthew Dy argues represents a 20-year industry failure, not a quality principle. Dy reframes 'process is the product' constructively: if the process is literally the product, then full process understanding allows incremental change to be built into the process itself, and platform knowledge can be aggregated and reused across regulatory submissions — unlocking scale and economics for rare disease programs. (Segment 2 (05:00-10:00))