Manufacturing Strategies To Industrialize Autologous Therapies

Autologous cell therapies are reshaping the future of personalized medicine by harnessing a patient’s own cells to fight disease. With regulatory approvals — particularly in oncology and CAR-T therapies — gaining momentum, the promise of these treatments is clear. Yet, as more therapies advance through the pipeline, the industry faces a pressing challenge: how to scale these highly individualized treatments efficiently, reliably, and cost-effectively.

Because autologous therapies require a unique batch for each patient, manufacturing is inherently complex. Processes such as cell collection, shipping, culture, labeling, and final formulation demand strict control to avoid errors or contamination. Critical quality attributes, including potency, viability, sterility, and purity, must be tested rapidly to ensure timely delivery, given the limited shelf life of these therapies. These complexities drive up the cost of goods, heighten risk, and present barriers to broader adoption.

Catalent’s Manufacturing by Design (MbD) methodology directly addresses these challenges. Building on the principles of Quality by Design, MbD extends beyond product quality to optimize efficiency, reduce cost, and safeguard supply chains. By integrating process automation, flexible infrastructure, and risk-based strategies, Catalent helps innovators streamline production and accelerate time-to-market — bringing life-changing cell therapies to patients faster and more reliably.