"This license is a strategic investment to build up a technology platform for the cell-therapy contract manufacturing business," says Lukas Utiger, Lonza's chief operating officer. "Cellular therapies are the logical progression for Lonza as we move from small molecules, then to biologics, and now therapeutic cells. Human induced pluripotent stem cells are widely viewed as having great potential in the field of cell therapy because these cells have the unique ability to become any of the 220-plus cell types in the adult body. iPSC also can be used for autologous therapies, something that isn't possible with embryonic stem cells. While there are some opportunities in the research space, we are building capabilities and expertise to support cGMP manufacturing of iPSC-derived cellular therapies, which we believe is a market that offers significantly more commercial potential. We already are in discussions with a few clients related to cGMP manufacturing."  

 

The partnership with iPS Academia Japan came about based on the organization's early work. In 2007, Dr. Shinya Yamanaka and colleagues at Kyoto University successfully converted adult human cells to an embryonic stem cell-like state, producing a human induced pluripotent stem cell line. The following June, iPS Academic Japan was established to manage the intellectual property stemming from this achievement.

 

By gaining rights to these patents, Lonza is adding to its portfolio of cell therapy products and services that includes process development and assay development as well as manufacturing therapeutic cells under current Good Manufacturing Practices (cGMP). The company is poised to apply its expertise in the manufacture of therapeutic cells to iPSC generation and cell banking, which it sees as an important first milestone necessary to bring an iPSC-based therapy to the clinic.

 

"As the iPSC field advances and clinical applications become closer to reality, Lonza is ready to support our clients in navigating the significant hurdles of process scale-up and optimization, cGMP manufacturing and regulatory compliance," says Utiger. "In our pluripotent stem cell technologies group, we continue to help our clients by 'building bridges from research to therapy.' With this license in place, we are well positioned to support our clients as they move from the research laboratory to a cGMP cell therapy suite."

 

Lonza's Pluripotent Stem Cell Innovation Center, located in Walkersville, Md., is focused on developing tools and technologies to help translational researchers and cell-therapy developers move iPSC technology to clinical application, Utiger notes.

 

"We are currently focusing on cGMP iPSC generation, a cGMP-compliant PSC medium and differentiation," he says. "The majority of our differentiation projects stem from participation in consortiums or client specific projects. For both, Lonza adds value as iPSC researchers move from laboratory studies to clinical trials. Specifically, the consortiums and clients rely on our expertise in process development, scale-up and clinical-grade manufacture that meets the requirements of the regulatory authorities."

 

"iPS Academia Japan is pleased to grant a non-exclusive license to Lonza, a worldwide leader in life science contract manufacturing. Lonza is an ideal partner to drive iPSC technology towards commercial success," adds Shosaku Murayama, president and CEO of iPS Academia Japan.  

 

An affiliate of Kyoto University, iPS Academia Japan's main role is to manage and utilize the patents and other intellectual properties held or controlled by Kyoto University and other universities in the field of iPSC technologies. Currently, its portfolio consists of more than 60 patent families (the total number of patent applications is about 220) in iPSC technology, and about 50 license arrangements have been executed with domestic or international partners.