A feasibility study conducted by Wacker Biotech GmbH on behalf of MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) using Fab fragments, demonstrated that Wacker's E. coli secretion system can offer a far simpler and more cost-effective way of obtaining high yields of antibody fragments, which are used for research, diagnostic and therapeutic applications. Under the joint agreement, 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.
Wacker's E. coli-based secretion system is a well established system for the production of monomeric proteins. However, the feasibility study commissioned by MorphoSys 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. Yields of secreted and active antibody fragments exceeded 2 grams per liter 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 as high as 7 grams per liter. The extracellular secretion facilitates straightforward purification of recombinant products and makes the whole manufacturing process far more efficient and cost effective. Under the joint agreement, MorphoSys gains access to Wacker's secretion system for producing antibody fragments. MorphoSys application will focus on the research phase for antibody generation, in both of MorphoSys's operating units.
Antibody fragments are engineered parts of whole antibodies and a relatively new class of therapeutics. 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.
'We are very pleased at the positive outcome of our cooperation and the scientifically remarkable results of the joint study,' says Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. 'Wacker's unique secretion system gives us the opportunity to produce antibody fragments even more efficiently for our own purposes and for our partnered projects.'
'The successful cooperation with MorphoSys shows that Wacker Biotech not only offers years of experience in producing actives according to GMP standards, but also provides highly attractive expression systems,' says Dr. Thomas Maier, Managing Director of Wacker Biotech. 'Our innovative technology greatly 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 HuCAL®-Fab antibody fragment. HuCAL® stands for Human Combinatorial Antibody Library and is meanwhile a state-of-the-art concept for the in-vitro production of highly specific human antibodies and antibody fragments for diagnostic and therapeutic purposes. HuCAL® technology offers a high-throughput process for the fast generation and selective optimization of antibodies.
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.
For further information please contact: Dr. Claudia Gutjahr-Löser, Director Corporate Communications, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, PR Specialist, Tel: +49 (0) 89 / 899 27-454, brkulj@morphosys.com