Mind the Gap: Bridging the ‘Valley of Death’ for U.S. Biomanufacturing

The edge of a subway platform has stenciled letters, "Mind the Gap"

By Kelvin H. Lee, director of the Manufacturing USA National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes and autoimmune disorders. Manufacturing medicine using biology presents different challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills. Biomanufacturing processes are hard to control, and the products are difficult to define as “identical” from batch to batch.

Despite these challenges, biopharmaceuticals are critical to public health because the advantages are significantly greater. Scientific understanding of diseases and the success of biologically manufactured therapies to treat them has increased dramatically. But it can take a decade from design to full production of a biopharmaceutical — not fast enough to meet the needs of all the patients, or to beat competition from overseas.