Cell Therapy Manufacturing

Why patient access to ATMPs must be improved?

A major cost driver is the high price of essential growth factors and recombinant proteins, which significantly impact the cost per liter of media used in cell expansion. For example, FGF-2—critical for pluripotent stem cell maintenance—can account for up to 50% of media costs, while human recombinant albumin (rhHSA), essential for cell viability and formulation, further inflates expenses. Together, these materials contribute to media costs ranging from $5,000 to $15,000 per liter, which can be futher increased while working with GMP-compliant media formulations, and thus making large-scale cell therapy production financially unsustainable.

Reducing Cell Therapy Manufacturing Costs to Increase Patient Access

Millions of patients worldwide suffer from diseases that could be transformed by cell therapies. Over 10 million people live with Parkinson’s disease, more than 18 million experience long-term effects of heart attacks, and nearly 200 million are affected by macular degeneration. While existing treatments manage symptoms, they do not restore function—something cell therapies could achieve.

The potential is clear: 2,000+ clinical trials are currently exploring cell-based therapies, including CAR-T cell treatments for cancer and human pluripotent stem cell-derived therapies for neurological and cardiovascular diseases. Approved therapies like Kymriah® and Yescarta® have already demonstrated life-saving efficacy. Yet, despite their potential, access remains a critical challenge.

One of the primary barriers to widespread adoption is the extremely high cost of cell therapy manufacturing. The production process is complex, requiring stringent quality controls, sophisticated bioprocessing, and expensive reagents. As a result, approved cell therapies often come with prohibitive price tags, such as $373,000 for Yescarta® and over $1 million for some autologous stem cell-based treatments. This makes these therapies inaccessible for many patients and places a significant burden on healthcare systems.

At Core Bioprocess, we are committed to breaking this cost barrier by providing high-purity, cost-effective growth factors and recombinant proteins through an innovative plant-based biomanufacturing platform. By significantly reducing the cost of these critical components without compromising quality, we aim to support a more scalable, affordable future for cell therapy manufacturing—ensuring that these groundbreaking treatments can reach the patients who need them most.

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