MedPage Today February 19, 2020
-Quality control, manufacturing capacity loom as obstacles
Gene therapy is finally poised to revolutionize the treatment of many diseases, but the nascent field is facing challenges — notably in manufacturing — that could limit its early success, experts tell MedPage Today.
With two chimeric antigen receptor (CAR) T-cell treatments and two more traditional gene therapies approved, plus a handful of gene therapy products in late-stage trials, excitement is high. But manufacturing bottlenecks, paired with quality control and talent pool concerns, raise questions about the pace of progress.
While there’s “a lot of exciting work” in gene therapy, Kelvin Lee, PhD, director of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), cautioned about what the field can deliver.
“I think...
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