Increased Comparability Burden During Clinical Trials
Source: Corning Life Sciences
As a therapy proceeds through Phases I / II and into Phase III clinical trials, the comparability burden increases. As the body of knowledge increases, the comparability burden evolves. Some tests may be removed while others are added, and assumptions may change with data. In this segment of Cell & Gene Live, "Scaling Cell Therapies Part 2: Establishing Comparability in Manufacturing," Michael Blackton and John Lee break down the comparability requirements from early- to late-stage programs.
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