Introgen sets sights on CMO sector
and storage technologies have allowed it to broaden the scope of
its contract manufacturing operations and set up a new unit called
Introgen Technical Services (ITS).
In 2007, Introgen announced that it had determined the optimal formulation for a storage-stable adenovirus, allowing it to build up inventories of leading in-house development candidates like Advexin p53 and Ingn 241 mda-7 for clinical trials.
This enabled it to use the freed-up production capacity to expand its contract manufacturing operations, which generated around $468,000 (€303,218) in the final three months of last year.
The new ITS unit, which will operate out of Introgen's Texas facility, is intended to provide clients with a broad range of good manufacturing practice (GMP) accredited process and fill/finish capabilities, with a particular focus on helping drugmakers scale-up from laboratory to clinical study sized production runs.
While the contract manufacturing market is undoubtedly attractive for firms with spare otherwise idle capacity, particularly the biologics sector that Introgen is targeting, the presence of many dedicated contract manufacturing organizations (CMO) mean that competition is likely to be tough.
Additionally, in light of the recent debate surrounding the results of a Phase III of Advexin, which showed that the drug conferred a survival benefit compared with methotrexate in only a specific subset of subjects, Introgen's move could be seen as part of an effort to diversify.
Introgen Alliance with Texas A&M Introgen also announced that it has teamed up with the Texas A&M University System to examine opportunities for process development and production in the biopharmaceutical industry.
The alliance is intended to serve organizations working in the fields of biological, medical, chemical, engineering and industrial sciences, specifically in ares of GMP compliant production, industrial process development, and scale-up services.
The project will focus on production of therapeutics, vaccines and drug delivery systems for human and veterinary applications.
It will also seek to develop new methods, standards and intellectual properties to advance healthcare research and regulation of new healthcare technologies.
Max Talbot, Introgen's senior vice president of world wide commercial development, said that the partnership " is a very logical next step for leveraging Introgen´s knowledge and assets in GMP production and compliance areas ."
Dr Talbot, who will also become CEO of ITS, added that the firm's " process development and manufacturing capabilities are assets which can be deployed to address broader markets ."
