Gradipore has entered into a research agreement with Aventis Behring L.L.C. for the separation and purification of immune globulins (IgG), from plasma fractions utilizing Gradipore's platform separations technology, Gradiflow, a unique membrane-based biological separations process. The project will include the establishment of parameters, tests, and further validation of the scale-up of Gradiflow technology. This effort will also test the feasibility of a full-scale industrial IgG separation and purification scheme.

Intravenous IgG (IVIG), which consists of disease-fighting antibodies extracted from blood plasma, is increasing in demand internationally. Technology which will increase the yield of IgG from plasma may help address this increased demand for the therapeutic use of IVIG. The worldwide IVIG market is expected to grow from $1.62 billion in 2002 to $2.5 billion in 2010.

"One of the key differentiating qualities of the Gradiflow system is its ability to rapidly separate plasma components based on size and charge in biological samples," said Ulrich Delvos, Senior Vice President, Research and Development and Chief Scientific Officer, Aventis Behring. "Our aim is to explore the feasibility of the process in large-scale applications, and verify the potential for a significant increase in IgG yields from plasma fractions, which may be obtained using this novel and exciting technology."

For Gradipore, this agreement may provide further scientific validation of the Gradiflow technology. IgG antibody constitutes approximately 70% of serum immune globulin and is the major antibacterial, antifungal and antiviral antibody. For Aventis Behring, this agreement provides access to the Gradiflow technology and a process by which higher IgG production yields may be achieved. Under terms of the agreement, Gradiflow will be evaluated for isolation and purification of IgG from various plasma fractions.

Dr. Hari Nair, CEO of Gradipore Inc said, "the ability to deliver higher yields of IgG from plasma products is crucial, and the Gradiflow separation technology has already been demonstrated to successfully separate components of human plasma. This collaboration with Aventis Behring, a worldwide leader in the therapeutic protein industry, will permit us to further expand the number of organizations who are exploring the feasibility of the Gradiflow process in large-scale commercial applications."

Gradipore's core separations technology platform, Gradiflow, is a unique membrane-based process for large-scale biological separations and has a wide range of applications in research, scientific and commercial environments including blood purification and biological drug manufacturing. Unlike other large-scale blood purification technologies, Gradiflow can purify proteins and remove viral and bacterial pathogens simultaneously.