Launching Regenerative Medicine Contract Manufacturing Business in Japan
OREANDA-NEWS. Nikon Corporation (Kazuo Ushida, President) signs a strategic collaboration agreement (Facility Support and License Agreement) with Lonza (Richard Ridinger, CEO, Basel, Switzerland), 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.
1. Background of partnership
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.
2. Purpose for entering the regenerative medicine 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 realize 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 realization 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 optimize the manufacture of high-quality cells and to provide clinical solutions including both hardware and software from Japan to international market.
3. Overview of New Company
| Company Name | Nikon CeLL innovation Co., Ltd. |
|---|---|
| Representative Director | Toshiyuki Nakayama |
| Location | To be determined (Tokyo/Yokohama area under consideration) |
| Time of Establishment | First Half of FY2015 |
| Commencement (*) of Contract Manufacturing business | Second Half of FY 2015
|
| Completion of construction of facility | First half of FY 2017 |
| Main Business |
|
| Amount of investment | 2 billion Yen (Paid-in capital 1 billion Yen and Capital reserve 1 billion Yen) Wholly-owned by Nikon Corporation |
This subsidiary is affiliated with Microscope Solutions Business Unit.
The revenue from this business is expected to be reported on and after FY2017.
About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. It harnesses science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
Not only is it a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 full-time employees worldwide. The company generated sales of about CHF 3.64 billion in 2014 and is organized into two market-focused segments: Pharma & Biotech and Specialty Ingredients. Further information can be found at www.lonza.com.
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