WALKERSVILLE, Md.—Lonza Biosciences has entered into aworldwide, non-exclusive licensing agreement with iPS Academia Japan Inc. forits induced pluripotent stem cell (iPSC) patent portfolio.
"This license is a strategic investment to build up atechnology platform for the cell-therapy contract manufacturing business," saysLukas Utiger, Lonza's chief operating officer. "Cellular therapies are thelogical progression for Lonza as we move from small molecules, then tobiologics, and now therapeutic cells. Human induced pluripotent stem cells arewidely viewed as having great potential in the field of cell therapy becausethese cells have the unique ability to become any of the 220-plus cell types inthe adult body. iPSC also can be used for autologous therapies, something thatisn't possible with embryonic stem cells. While there are some opportunities inthe research space, we are building capabilities and expertise to support cGMPmanufacturing of iPSC-derived cellular therapies, which we believe is a marketthat offers significantly more commercial potential. We already are indiscussions with a few clients related to cGMP manufacturing."
The partnership with iPS Academia Japan came about based onthe organization's early work. In 2007, Dr. Shinya Yamanaka and colleagues atKyoto University successfully converted adult human cells to an embryonic stem cell-likestate, producing a human induced pluripotent stem cell line. The followingJune, iPS Academic Japan was established to manage the intellectual propertystemming from this achievement.
By gaining rights to these patents, Lonza is adding to its portfolioof cell therapy products and services that includes process development andassay development as well as manufacturing therapeutic cells under current GoodManufacturing Practices (cGMP). The company is poised to apply its expertise inthe manufacture of therapeutic cells to iPSC generation and cell banking, whichit sees as an important first milestone necessary to bring an iPSC-basedtherapy to the clinic.
"As the iPSC field advances and clinical applications becomecloser to reality, Lonza is ready to support our clients in navigating thesignificant hurdles of process scale-up and optimization, cGMP manufacturingand regulatory compliance," says Utiger. "In our pluripotent stem celltechnologies group, we continue to help our clients by 'building bridges fromresearch to therapy.' With this license in place, we are well positioned tosupport our clients as they move from the research laboratory to a cGMP celltherapy suite."
Lonza's Pluripotent Stem Cell Innovation Center, located inWalkersville, Md., is focused on developing tools and technologies to helptranslational researchers and cell-therapy developers move iPSC technology toclinical application, Utiger notes.
"We are currently focusing on cGMP iPSC generation, acGMP-compliant PSC medium and differentiation," he says. "The majority of ourdifferentiation projects stem from participation in consortiums or clientspecific projects. For both, Lonza adds value as iPSC researchers move fromlaboratory studies to clinical trials. Specifically, the consortiums andclients rely on our expertise in process development, scale-up andclinical-grade manufacture that meets the requirements of the regulatoryauthorities."
"iPS Academia Japan is pleased to grant a non-exclusivelicense 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 mainrole is to manage and utilize the patents and other intellectual propertiesheld or controlled by Kyoto University and other universities in the field ofiPSC technologies. Currently, its portfolio consists of more than 60 patentfamilies (the total number of patent applications is about 220) in iPSCtechnology, and about 50 license arrangements have been executed with domesticor international partners.