As a new consortium of researchers, clinicians, and engineers from academia, industry, and government work toward a common goal of expanding the use of cell therapies, engineers are playing a critical role in developing proper manufacturing techniques and standards for mass production for this emerging industry.

To highlight the important role engineers will play in the industry, the National Science Foundation (NSF) last fall awarded [Georgia Tech] nearly $20 million to support a new engineering research center to facilitate mass production.

The grant was awarded around the same time the Food and Drug Administration approved the first two gene therapy treatments, Novartis’s Kymriah and Kite’s Yescarta, which were followed by the approval of Spark Therapeutics’ Luxturna in December. More than 300 biotech and pharmaceutical companies are currently working on cell and gene therapy products.

The skills needed to meet the manufacturing complexities, scale and quality assurance in the production of those therapies is creating a demand for engineering expertise

“Its time has come because these products are now coming onto market without any clear path on how people can manufacture them for a broader base,” says Krishnendu Roy, director of the recently established NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT) and Marcus Center for Cell Manufacturing at Georgia Institute of Technology. The Atlanta-based university leads a consortium that includes other universities in the U.S. and abroad, industry, and U.S. national laboratories.

“We started thinking in this area about three or four years ago,” Roy says.

One of the first major steps in creating the consortium was developing a 60-page, 10-year roadmap that laid out challenges and barriers, as well as a technological wish list for the next 10 years. More than 25 companies and 15 academic institutions collaborated to produce the roadmap.

See the complete article from the Alliance of Advanced BioMedical Engineering (AABME) website.