Pioneering recombinant growth hormone manufacturing: pounds produced per mile of height.

The first efforts to produce recombinant human growth hormone (GH) for clinical use were begun by scientists at Genentech, Inc., almost a generation ago, late in 1979. The very small market for GH that was predicted at the time led to this manufacturing effort being done as a demonstration project. Among the early issues was whether the Escherichia coli host cell could be routinely produced in a stable manner and be inactivated after the GH production run (as required by Federal guidelines) without the GH being permanently denatured. A 10 L E. coli process was developed, and phase I testing began in early 1981. The approval of this recombinant GH product by the FDA in 1985 paved the way for many improvements and a sustained production effort in the next decade. The more than 1990 fermentation runs have produced tons of E. coli and more than 130 pounds of GH for both clinical research and the treatment of severely short children.