A small German start-up company has turned to Boehringer Ingelheim to develop a process for the production of a new monoclonal antibody-based drug for immunological disorders.
The company, TeGenero, has asked BI to generate a production cell line, build a manufacturing process and produce sufficient quantities of the humanised antibody - called CD28-SuperMAB, to complete clinical trials.
BI said it has been given the task of supplying enough of the antibody to complete the clinical development of the drug in both the European Union and the US.
The new deal fits with an emerging trend in biopharmaceutical outsourcing, in which the major growth in the sector is being seen from small biopharmaceutical research companies which lack internal production capabilities. The often-cited R&D productivity gap among the bigger pharmaceutical players means that their own in-house capacities are often sufficient for their needs. And in some cases they are also dabbling with contract manufacture themselves to make use of an excess in capacity.
Echoing this view, Wolfram Carius, vice president of biopharmaceuticals at BI, noted that the company has "a commitment to team up with start up companies worldwide."
The company already makes five of the most internationally successful biopharmaceutical products, with contract manufacturing deals in place with Amgen (for the rheumatoid arthritis drug Enbrel; etanercept), InterMune, MedImmune, Schering and Wyeth.
TeGenero's antibody is also known as TGN1412 and is currently in preclinical development. It stimulates the activity of T lymphocytes and could be used, for example, to upgrade a patient's immunological response to cancer. It may also be used in a regulatory way, for instance by switching off T cells involved in autoimmune diseases such as rheumatoid arthritis.