April 8, 2010
New Meds Faster
Biomolecules are medicine's jacks-of-all-trades: They are suitable for the diagnosis and treatment of cancer diseases; they are used in the treatment of multiple sclerosis and asthma; they help stimulate the build-up of the body's own immune defenses with flu and polio inoculations. In the laboratories of the pharmaceutical industry, new biomolecules are constantly being engineered: Specific antibodies, customized proteins and nucleic acids "“ the core components of genetic material - are considered promising candidates for therapeutic approaches.
"Medical-pharmacological research will soon be using more biomolecules than ever before. Processes will be increasingly needed with which these biomolecules can be produced rapidly, in sufficient quantities and of clinically quality," says Dr. Holger Ziehr, who heads the pharmaceutical biotechnology department of the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM at its Braunschweig site. "Our new platform technologies meet these performance capabilities: We can synthesize nearly any antibody, protein or nucleic acid in cell cultures "“ irrespective of their binding properties and base sequences." The systems for producing customized biomolecules meet the "Good Manufacturing Practice" "“"GMP" "“ quality standard of the European Medicines Agency EMA as well as the USA's Food and Drug Administration FDA.
"The Fraunhofer GMP platform technologies are not only extraordinarily versatile for this, they also help save a lot of time in the production and development of candidates for biopharmaceutical substances," explains Ziehr. "We can offer industry customers our full expertise "“ from the production of tailored biomolecules to preclinical tests based on 'Good Laboratory Practice' "“ 'GLP' "“ through to clinical investigations per the GCP or 'Good Clinical Practice' standard. Outside of the major pharmaceutical corporations in Germany, there is nothing else like this except at the Fraunhofer-Group for Life Sciences."
On the Net: