Lonza, the world’s leading developer and manufacturer of cells for regenerative medicine therapeutics, and Nikon Corporation announced today an exclusive collaboration in the field of cell and gene therapy manufacturing in Japan. Nikon will have access to Lonza’s quality and operating systems, facility design and ongoing consulting services for the establishment of a wholly owned Nikon cell and gene therapy contract manufacturing business. The Tokyo/Yokohama area of Japan is currently under consideration for the site location of the Nikon’s new facility.
Japan has become an attractive location for the future of regenerative medicine since the induction of the Revised Pharmaceutical Affairs Act, which became effective in November 2014. The act states conditional product approval may be granted in Japan at the time when clinical safety and an indication of efficacy of a regenerative medicine product are demonstrated. For this reason Japan is expected to be a promising location for the expedited clinical application of cell and gene therapy products.
The use of somatic stem cells (hematopoietic stem cells and mesenchymal stem cells) has already gained traction in the United States and European biotechnology and pharmaceutical markets, with the use of induced pluripotent stem cells (iPSCs) following quickly behind.
In addition, virally modified gene therapy has demonstrated promising clinical results in multiple disease indications, including cancer. Using viral vectors, immune and stem cells can be genetically modified and reintroduced to the patient as a targeted therapy.
The global reach of the regenerative medicine market and the advancement of stem cell manufacturing have driven this collaboration in Japan. With this collaboration Nikon will benefit from Lonza’s extensive track record in global cell manufacturing, while expanding its entry into the contract manufacturing market. Nikon will acquire the technical know-how to differentiate and manufacture cells, including somatic stem cells, as well as Lonza’s quality and safety evaluation standards and operational procedures in the manufacturing process. This collaboration will accelerate Nikon’s efforts to realize future practical applications of iPSCs in the field of regenerative medicine.
“This collaboration will contribute greatly to the growth of the global cell and gene therapy market,” said Andreas Weiler, Head of Emerging Technologies, Lonza Pharma&Biotech. “We are utilizing our expertise built over the last decade to work together with Nikon in bringing high-quality, innovative development and manufacturing to Japan. Because of its work in iPSC technology, we believe Nikon is an ideal partner for this collaboration in regenerative medicine.”
Nikon’s newly formed subsidiary, Nikon CeLL innovation Co., Ltd., will actively contribute to the early realization of Japan’s regenerative medicine market and over time will expand its business domain into adjacent technology areas. Furthermore, Nikon will also develop equipment and disposables needed to optimize the manufacture of high-quality cells, along with hardware and software from Japan to the international market.