Nikon Corporation, a Japanese company specialising in optics and imaging products, has signed a strategic collaboration agreement (Facility Support and License Agreement) with Lonza, the world’s largest manufacturer of cells for regenerative medicine therapeutics, to establish a new company, wholly-owned by Nikon, dedicated to regenerative medicine contract manufacturing.
The agreement includes access to Lonza’s quality and operating systems, facility design and on-going consulting services for the establishment of the contract manufacturing facility in Japan.
"Contract manufacturing of regenerative medicine products" is the business which manufactures and supplies cell products to be used for regenerative medicine under an outsourcing contract with a pharmaceutical company.
With the Revised Pharmaceutical Affairs Act, which became effective in November 2014, a conditional product approval may be granted in Japan at the time clinical safety and an indication of efficacy of a regenerative medicine product is shown. For this reason, Japan is attracting attention as the most promising location where expedited clinical application of regenerative medicine is the expected.
The use of somatic stem cells (hematopoietic stem cells and mesenchymal stem cells) has already started in the United States and Europe with the clinical use of induced pluripotent stem cells (iPSCs) following quickly behind. Somatic stem cells have challenges, including their limited ability to differentiate, their scarcity in the body and the difficulty in maintenance and expansion ex-vivo. However, early clinical applications and manufacture of somatic stem cells in regenerative medicine have been successful due to their safety profile and ability to be extracted directly from the human body. Therefore international collaboration for their manufacture and supply is advancing.
Nikon, considering the above-mentioned environment around regenerative medicine, believes that developing the capabilities to contract-manufacture high-quality regenerative medicine products in Japan is urgently needed. Therefore, Nikon has formed a strategic collaboration with Lonza, which has an excellent track record in the global development and manufacture of cell products for regenerative medicine, and will enter into the contract manufacturing business.
By entering into cell product contract manufacturing business, Nikon will acquire the know-how to manufacture cells, including somatic stem cells, and will accelerate its effort to realise future practical applications of iPSCs in the field of regenerative medicine.
Since 2007, Nikon’s instrument business unit has been developing a sales and manufacturing business named BioStation CT, which produces cell culture observation system for live cells including iPSCs.
For the future practical applications of iPSCs in regenerative medicine, however, it is necessary to establish the quality and safety evaluation standards and operational procedures of the manufacturing process. Considering the method of differentiation into every cell species and the large-scale cell culture needed, scale-up know-how is critical to successful manufacturing.
Nikon will actively be engaged for solution of these issues by introducing the high-quality cell manufacturing technology and technical know-how from Lonza, together with Nikon’s core technology, optics technology and image analysis technology for successful cell contract manufacturing activity.
By entering into a new regenerative medicine contract manufacturing business, Nikon will actively be contributing to the early realisation of Japan’s regenerative medicine, and will expand its business domain into adjacent technology areas.
Furthermore, Nikon will prepare for the major breakthrough in regenerative medicine market driven by iPSCs and will also be developing equipment and disposables needed to optimise the manufacture of high-quality cells and to provide clinical solutions including both hardware and software from Japan to international market.