Introgen Therapeutics, Inc. has been granted a broad patent by the European Patent Office (EPO) that relates to the production of purified adenoviral compositions that are commercially scaleable and can be readily validated for regulatory purposes.
The patent, number 0968284, is entitled "An Improved Method for the Production and Purification of Adenoviral Vectors." This patent complements three previously issued US patents in Introgen's intellectual property portfolio related to the production of adenoviral vectors. Several products in Introgen's clinical programme utilize adenoviral vectors and the processes covered under this newly issued patent were developed exclusively at Introgen.
David L Parker, PhD, JD, Introgen's senior vice president of Intellectual Property commented, "This patent is the European complement to our existing US adenovirus production/purification technology. It is of particular importance in that it covers the production of adenovirus of commercial scale quantity and purity, regardless of whether the adenovirus is used as a delivery system for therapeutic genes, used directly as a therapeutic agent, used as a vaccine or vaccine component or simply used for research and development purposes.
The purification technology covered by this patent is currently being employed throughout the industry by Introgen and others, and is thus recognized as an industry standard for clinical production of adenovirus."
"We believe this key enabling technology validates Introgen's leadership in adenovirus production and purification technology," said Peter Clarke, PhD, Introgen's vice president of production and technical processes. "This patent arises out of our extensive process development efforts at Introgen. The underlying technologies have been validated by our ability to supply high quality adenoviral vectors for our clinical development programmes and by the selection of Introgen, under a process guided by the Food and Drug Administration, to manufacture the worldwide adenoviral reference material for use by companies and academic institutions developing adenovirus-based products.
Adenovirus has been used in hundreds of thousands of patients in government, industry and academia for vaccine and therapy programmes. Adenoviruses can be genetically altered so that they are unable to replicate in humans and they do not mix with a patient's DNA.