German partners to manufacture GE cancer inhibitor
genetically engineered drug made from a vegetable substance.
The government-funded research institute GBF has found a way to industrially produce the plant protein viscumin, a cancer inhibitor, allowing it to be tested in large clinical trials.
GBF, the German Research Centre for Biotechnology in Braunschweig, and biopharma company Viscum have jointly developed the viscumin manufacturing process by isolating the gene of the mistletoe substance and implanting it in the intestinal bacterial Escherichia coli.
"The bacteria can produce viscumin in much larger quantities than the plant itself, and they produce it in a consistent quality," explained Dr Martin Langer, business development manager at Viscum.
For the medical profession, this means it is easier to administer more appropriate dosages than with mistletoe extract, whose composition and quality fluctuate substantially.
Viscumin belongs to the lectin class of proteins and is an immune system stimulant with cancer-inhibiting properties. The compound produced from this substance, aviscuminum, is currently undergoing large-scale clinical testing by Viscum, which focuses on new medicines made from natural ingredients, especially cancer drugs.
"The required clinical test phases will almost certainly take a few more years," noted Dr Langer.
However the partnership with GBF has allowed the firm to obtain quality samples for clinical testing. Before medical efficacy tests can be conducted on patients, high-quality samples must be manufactured in suitable quantities under GMP guidelines. Unusually for a public institute, GBF possesses the pharmaceutical certification for GMP production.
The organisation devised the scale-up procedures from laboratory quantities to bio-reactor production and has also developed a robust production process.