Antibody fragments are engineered parts of whole antibodies and a relatively new class of therapeutics that is gaining significance with the pharmaceutical industry.
Several antibody fragment based medicines are already undergoing phase 3 clinical trials. One therapeutic antibody fragment is currently marketed under the brand name ReoPro.
Fragments have several advantages over whole antibodies, in particular, lower manufacturing costs and faster production cycles.
Under the terms of the joint agreement, biotechnology company, MorphoSys, obtains the right to use Wacker's secretion system for antibody-fragment production in research quantities for therapeutic projects both on its own behalf and with its commercial partners.
MorphoSys in turn will focus on the research phase for antibody generation, in both of MorphoSys' operating units.
The deal came about as a result of a recent feasibility study conducted by Wacker Biotech on behalf of MorphoSys using Fab fragments, which demonstrated that Wacker's E. coli secretion system can offer an improved way of obtaining high yields of antibody fragments.
The study proved for the first time that production of Fab antibody fragments is also possible. Wacker's E. coli-based secretion system proved highly effective in the expression of a MorphoSys antibody fragment with therapeutic potential.
In the study, yields of secreted and active antibody fragments exceeded 2 grams per litre in the supernatant. This result is especially remarkable since the antibody fragments are assembled from two different sub-units and have intramolecular disulfide bridges.
Wacker's system has already been used to produce other proteins in yields of 7 grams per litre.
The extracellular secretion facilitates straightforward purification of recombinant products and makes the whole manufacturing process far more efficient and cost effective.
"We are very pleased at the positive outcome of our cooperation and the scientifically remarkable results of the joint study," said Dr. Marlies Sproll, chief scientific officer of MorphoSys.
"Wacker's secretion system gives us the opportunity to produce antibody fragments more efficiently for our own purposes and for our partnered projects," he added.
The successful cooperation with MorphoSys shows that Wacker Biotech not only offers experience in producing actives to GMP standards, but also provides attractive expression systems," says Dr. Thomas Maier, managing director of Wacker Biotech.
"Our technology reduces the cost-of-goods factor, creating substantial added value for customers."
The study targeted a promising candidate from the MorphoSys proprietary development pipeline - a Human Combinatorial Antibody Library (HuCAL-Fab) antibody fragment - a concept for the in-vitro production of highly specific human antibodies and antibody.
Wacker's proprietary E. coli K12-based expression system transfers recombinant proteins in native form to the fermentation broth during fermentation.
The system consists of specific expression plasmids and a proprietary E. coli K12 strain that transfers proteins from the periplasma into the medium in high yields. The E. coli strain is stable during fermentation.