Lonza, Nikon Form Gene Therapy Mfg Pact
Lonza and Nikon Corporation have formed 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.
Lonza notes that 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.
Nikon's newly formed subsidiary, Nikon CeLL innovation Co., Ltd., will target Japan's regenerative medicine market and over time plans to 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.