PIONEERING RECOMBINANT GROWTH-HORMONE MANUFACTURING - POUNDS PRODUCEDPER 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 ge neration ago, late in 1979. The very small market for GH that was pred icted at the time led to this manufacturing effort being done as a dem onstration 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 guidel ines) without the GH being permanently denatured. A 10 L E. coli proce ss was developed, and phase I testing began in early 1981. The approva l 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 1900 fermentation runs have produced tons E. coli and more than 130 pounds of GH for both clinical research and the treatmen t of severely short children.