Expanding the Horizons of Biologics Gene Techno Science Co., Ltd. IP

Gene Techno Science Co., Ltd. develops biologics and biosimilar pharmaceuticals using a “fabless” development structure that gives it the speed and flexibility to compete with big pharmaceutical companies. Meanwhile, the sheer difficulty of developing manufacturing processes for biosimilars gives the company a treasure-trove of know-how that is hard to match.

As patents on the world’s longstanding stock of chemical-based small molecular drugs continue to lapse, many pharmaceutical companies are turning to biologics—large-molecule drugs developed from biological sources—in search of new intellectual property.

“The world is shifting more and more to biologics,” says Masanari Kawaminami, president of Gene Techno Science. The company was formed in 2001 by scientists at Hokkaido University to develop biologics and what are called “biosimilar” pharmaceuticals: generic treatments based on lapsed-patent biologics.

The extreme difficulty of development means simply establishing the manufacturing process for a biosimilar creates a stock of know-how unique to the company. “There are only about two Japanese pharmaceutical manufacturers that make their own biologics,” Kawaminami explains. “There are few companies that have the manufacturing know-how.”

However, rather than engage in manufacturing itself, Gene Techno Science partners with various organizations—including technology companies, distributors, contract research organizations and contract manufacturing organizations—to completely outsource fabrication. Kawaminami says this fabless structure gives his organization speed and flexibility that offer advantages over larger pharmaceutical manufacturers.