Footprint size matters in cell and gene therapy manufacturing

Cell and gene therapies have demonstrated their extraordinary, curative potential in the last decade. They’ve had the biggest impact in liquid tumors, but with over 1000 clinical trials in the advanced therapy space underway, cures for a range of diseases are on the horizon.

The latest ground breaking news in the space is the European Marketing Authorization for Kite’s Yescarta as a second line treatment for B-cell diffuse lymphoma. Until now, CAR-T therapies have only been approved for refractory patients, with patients having to undergo at least 2 lines of treatment before being eligible. But with the increased focus on getting cell and gene therapies to market, the expansion of approved therapies to wider patient populations, and the use of these therapies earlier in the treatment pathway, manufacturing capabilities need to be drastically improved to meet the oncoming demand.

This opens up a plethora of problems. Aside from the commonly discussed issues; the lack of qualified manufacturing personnel, supply chain issues with reagents and plasticware, the high batch failure rates plaguing manufacturing processes, and the logistics of delivering cell therapies to patients; there simply isn’t enough space for large-scale cell and gene therapy manufacturing. So how big is this problem? Let’s do a rough breakdown:

1 clean room = ~150sqm

à This can run 10 simultaneous batches with the best automated platforms on the market

For a typical CAR-T process with a team working full day and night shifts:

1 batch = 2 weeks

So in 1 year: 10 batches x 2 weeks x 12 months = 240 batches

Currently CAR-T manufacturing represents less than 1% of clean room utilization and the number of patients treated with cell therapies every year is in the thousands. But the addressable population for just CAR-T therapy is going to be ~2 million patients in the next 5-10 years. Which will require:

8,000 clean rooms = 1,200,000 sqm

That’s equivalent to the current total cleanroom capacity worldwide.

In reality, this space should be doubled to factor in space for QC labs, storage space, offices etc, and including the manufacture of non-CAR-T cell therapies this requirement could even be tripled. This substantial need for more space is good news for clean room suppliers. But the space and construction requirements, and the expensive equipment needed to run these clean rooms to regulatory standards isn’t so good for cell and gene therapy developers, patients or the environment.

At MFX we are developing the Cyto Engine™, an automated cell therapy manufacturing platform that can produce up to 100 batches per square meter. That’s more than 30x the number  of batches per square meter than current manual processes, and more than 4x the number of batches per square meter than current automated processes.