Manufacturing Strategies to Industrialize Autologous Therapies
Summary: Autologous cell therapies promise life-changing treatments but face steep barriers in scalability, cost, and reliability. Each patient batch is unique, adding complexity, risk, and expense to manufacturing. This white paper introduces Catalent’s Manufacturing by Design (MbD) methodology, a structured framework to improve efficiency, reduce cost of goods, and strengthen supply continuity. By applying MbD from early development through commercial scale, innovators can better manage variability, accelerate timelines, and ensure therapies reach patients faster and more reliably.