Scaling Up CAR-T Therapies Requires Overcoming Manufacturing, Regulatory And Distribution Challenges

Recent approvals of CAR-T immuno-oncology therapies present a market opportunity estimated to grow nearly 50 percent annually over the next decade, exceeding $8.5 billion globally by 2028. Taking advantage means scaling up CAR-T production to industrial levels. This presents several highly technical and interrelated manufacturing, regulatory and distribution challenges.

Partnering with a clinical research organization experienced in immuno-oncology, such as ICON, can provide the manufacturing and distribution, and regulatory expertise sponsors will need to succeed. Here, we outline some significant challenges of scaling up CAR-T, and potential solutions.