Swiss fine and specialty chemicals producer Lonza, which claims to be the world's leading developer and manufacturer of cells for regenerative medicine therapeutics, has entered an exclusive cooperation with Japan's Nikon covering cell and gene therapy manufacturing in Japan.

Under the terms, Nikon will have access to Lonza's quality and operating systems, facility design and ongoing consulting services for the establishment of a wholly owned cell and gene therapy contract manufacturing business under the name Nikon CeLL innovation Co. The Tokyo/Yokohama area of Japan is currently under consideration for the location of the new facility.

Nikon will acquire Lonza's technical know-how to differentiate and manufacture cells, including somatic stem cells, as well as the Swiss company's quality and safety evaluation standards and operational procedures in the manufacturing process.

Since the adoption of the Revised Pharmaceutical Affairs Act in November 2014, Japan has become an attractive location for the future of regenerative medicine, Lonza notes. According to the legislation, conditional product approval may be granted 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 company noted.

"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."

Nikon's newly created subsidiary plans to actively contribute to the early realization of Japan's regenerative medicine market and over time intends to expand its business domain into adjacent technology areas. Additionally, it will develop equipment and disposables needed to optimize the manufacture of high-quality cells, along with hardware and software from Japan to the international market.