Company demonstrates ability to manufacture for large therapeutic markets
COPENHAGEN, Denmark and PRINCETON, New Jersey – Symphogen A/S today announced the publication of data in the March 20, 2010 online edition of Molecular Biotechnology by Nielsen LS et al. [epub ahead of print] demonstrating the ability of its Sympress II technology to enable cost-effective production of recombinant polyclonal antibodies (rpAb) and antibody mixtures with batch-to-batch consistency that the Company believes could supply drug product for large indications such as cancer and infectious disease. The Sympress II results demonstrated single-batch production of compositions with as many as six antibodies with a controlled and appropriate distribution in the final product.
“These published results indicate that Symphogen is now the only company that has overcome previous production limitations for rpAbs and so has enabled the cost effective single batch production at cost of goods sold that compares favorably with monoclonal antibody manufacturing,”
stated Kirsten Drejer, M.Sc. and Ph.D., Chief Executive Officer of Symphogen.
“We very much look forward to deploying Sympress II in the manufacturing of the rpAbs in our pipeline as they proceed through preclinical and clinical trials.”
Symphogen employs target-speci?c rpAbs, which represent a new generation of antibodies that mimic the diversity, speci?city, and binding capability of the natural human immune system. Such rpAb preparations contain several specific antibodies, all of which in the Sympress II production system can be produced in the same culture vessel. The Sympress II technology takes advantage of industry standard fed batch manufacturing processes for controlled production of recombinant polyclonal compositions.
Sympress II builds upon Symphogen’s earlier Sympress I technology, which has demonstrated highly reproducible, stable single batch production, but has a lower yield due to site-specific integration of a single antibody gene per cell making it best tailored for drug production to niche indications. The Sympress II production system utilizes a combination of random gene integration together with a new high producer Chinese Hamster Ovary (CHO) cell line, Enhanced Chinese Hamster Ovary (ECHO), as well as other improvements, which generated the same stability and reproducibility as the Sympress I technology and on top of that resulted in more than 10-fold higher yields. Furthermore, the generation of rpAb compositions with completely different target specificities was demonstrated suggesting that the Sympress II production system is generally applicable to rpAb manufacturing for large indications.
Symphogen is developing superior antibody therapeutics (monoclonal, monoclonal mixtures and polyclonal) to help people with serious diseases and significant unmet medical needs. With its proprietary, unique Symplex? discovery and Sympress? manufacturing platforms, the company captures the diversity and specificity of the natural immune response in rationally designed recombinant antibody compositions. Symphogen is maturing a diversified pipeline of internal and partnered products across multiple indications including cancer, autoimmune and infectious disease. Symphogen is a private biopharmaceutical company headquartered in Copenhagen, Denmark, with a US subsidiary in Princeton, New Jersey.
Kirsten Drejer, Chief Executive Officer
+45 6118 7494 or +45 2210 9959
Adriann Sax, Chief Business Officer
+1 908 794 1085
Kathryn Morris (media)
+1 845 635 9828