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BioSante Gets Patents To Manufacture Proteins, Antibodies

BioSante Pharmaceuticals has received two new US patents directed to its 2A/Furin technology for expressing proteins. The first issued US patent, US Pat No, 7,709,224, covers methods for manufacturing recombinant antibodies.

BioSante Pharma said that by incorporating 2A/Furin technology into antibody-expression in viral vectors it is possible to rapidly generate stable, high producing antibody cell lines. The subsequent cell lines may greatly reduce the time and lower the cost of commercial antibody production.

BioSante Pharma claimed that 2A/Furin technology generates cell lines that express levels of antibodies suitable for commercial production in a matter of weeks, compared to months for current techniques, which gives the potential to dramatically reduce the costs required to generate commercial antibodies.

The technology allows for high-level, equimolar expression of two coding sequences using a single promoter that is applicable for generating expression vectors for in vivo gene therapy applications, pre-clinical target validation and lead identification as well as to rapidly generate high producer antibody cell lines that produce, in-vitro, high levels of mature antibody without requiring any amplification currently employed in antibody expression systems.

Additionally, the second issued US patent, US Pat No 7,714,199 covers additional adeno-associated virus (AAV) vectors containing the 2A/furin technology and methods for expressing antibodies in-vivo using these vectors and builds on already issued patents covering vectors and methods for producing antibodies in-vivo and in-vitro. The two new patents expire in 2023.

Stephen Simes, president and CEO of BioSante, said: “The patents are the fifth and six issued patents in our patent estate covering our 2A/Furin technology and add patent protection for an additional manufacturing technology for quickly generating antibody producing cell lines. Additional patent applications are pending outside the US.

“Our objective with this technology is to maximise its value to our stockholders in the shortest time possible. To this end on April 26, 2010 we announced entering an Option Agreement with an undisclosed large multi-national pharmaceutical company to obtain a non-exclusive worldwide license for the use of BioSante’s 2A/Furin technology in the expression of antibodies. The market for antibody products in 2008 was approximately $31bn and growing.”