New meds faster

Apr 08, 2010

Before a new medication arrives on the market, it must be tested on animal models and in humans. In order to conduct these tests, a substantial amount of the therapeutically effective substances are needed - such as proteins or nucleic acids, for example. At the BIO International Convention 2010 in Chicago from May 3 to 6, Fraunhofer researchers will present several processes with which biomolecules can be harvested quickly, robustly, reliably and with versatility - and all processes comply with the GMP standard.

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 ITEM at its Braunschweig site. "Our new platform technologies meet these performance capabilities: We can synthesize nearly any antibody, protein or nucleic acid in - 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 FDA.

For the production of the various classes of biomolecules, the researchers at ITEM are working closely with the Fraunhofer USA Center for Molecular Biotechnology CMB in Newark, Delaware. Three production systems in total are operated at both sites: In Braunschweig, there are bioreactors that produce antibodies in transgenic cells - here they use CHO cells, the cells from hamster ovaries that are commonly deployed in cell research. In addition, the intestinal bacteria E. coli are used for harvesting any . The Delaware-based specialists are able to produce proteins or peptides in plants using "molecular farming." The plants for this are infected with a virus non-toxic to humans that contains the genetic template for the synthesis of the desired biomolecule.

"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."

Explore further: Untangling DNA with a droplet of water, a pipet and a polymer

add to favorites email to friend print save as pdf

Related Stories

Test of maturity for stem cells

May 06, 2008

Stem cells are extremely versatile: They can develop in 220 different ways, transforming themselves into a correspondingly diverse range of specialized body cells. Biologists and medical scientists plan to ...

Detecting cancer early

Feb 01, 2010

A new testing method is being developed to detect cancer soon after the tumor has formed. It will identify characteristic substances in the blood which accompany a certain type of tumor. The first steps in ...

Automated Tissue Engineering on Demand

May 18, 2009

(PhysOrg.com) -- There is an increasing demand for skin. Manufacturers of pharmaceuticals, chemicals, cosmetics and medical engineering products need it in order to test the compatibility of their products ...

Nano fights cancer

Feb 17, 2006

They are only a few nanometers in size, but their impact is tremendous: The tiny particles drive cancer cells to their death in no time at all. At nano tech 2006 in Japan from February 21 to 23 Fraunhofer researchers ...

Recommended for you

Cultivation of microalgae via an innovative technology

Feb 27, 2015

Preliminary laboratory scale studies have shown consistent biomass production and weekly a thick microalgal biofilm could be harvested. A new and innovative harvesting device has been developed for ALGADISK able to directly ...

Refined method to convert lignin to nylon precursor

Feb 27, 2015

A new study from the Energy Department's National Renewable Energy Laboratory (NREL) demonstrates the conversion of lignin-derived compounds to adipic acid, an important industrial dicarboxylic acid produced for its use as ...

Living in the genetic comfort zone

Feb 26, 2015

The information encoded in the DNA of an organism is not sufficient to determine the expression pattern of genes. This fact has been known even before the discovery of epigenetics, which refers to external ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.