There are a number of companies that facilitate the development of induced pluripotent stem cell (iPSC) therapies, including Cellular Dynamics International (CDI), Ocata Therapeutics, RIKEN, and Cynata Therapeutics. Cynata is unique in its approach, in that it is creating allogeneic iPSC-derived MSCs to be used for GvHD. There are also a number of companies specializing in iPSC product development, including Axiogenesis (a dominant European competitor), Axol Bioscience, ReproCELL, and others.
However, Cellular Dynamics International is one of the most important market participants, because of its dominance in both market areas. Furthermore, it was recently acquired by FujiFilm Holdings Corporation in April 2015, strengthening both its financial and strategic position.
It also recently divided into two equally important business units, a Therapeutics Business Unit and a Life Science business unit.
CDI’s new Therapeutics business unit focus on “developing and bringing to market induced pluripotent stem cell (iPSC)-based therapies in the ocular, cardiac, Parkinson’s, and oncology spaces, with IND applications in all these therapeutic areas expected in the 2018-2020 time period.” Its new Life Science business unit will concentrate on “building the research products business by propelling innovative cell products, applications, and services into the fast growing iPSC marketplace. This business unit is already on a clear path to profitability.”
Introduction to Cellular Dynamics International, Owned by FujiFilm Holdings
Cellular Dynamics International (CDI) is headquartered in Madison, Wisconsin, and provides technical and sales support for both the U.S. and Japan. CDI was founded in 2004 and listed on NASDAQ in July 2013. The company had global revenues of $16.7 million in 2014 and currently has 155 employees. It also has an extremely robust patent portfolio containing more than 800 patents, of which 130 pertain to iPSCs.
According to the company, CDI “is the world’s largest producer of fully functional human cells derived from induced pluripotent stem (iPS) cells.” Their trademarked iCell® Cardiomyocytes, derived from iPSCs, are human cardiac cells used to aid drug discovery, improve the predictability of a drug’s worth, and screen for toxicity. In addition, CDI provides: iCell® Endothelial Cells for use in vascular-targeted drug discovery and tissue regeneration, iCell® Hepatocytes, and iCell® Neurons for pre-clinical drug discovery, toxicity testing, disease prediction, and cellular research .
To date, CDI’s main role with regard to iPCS therapy development has been the production of industrial-scale, clinical-grade iPSCs.
As mentioned previously, induced pluripotent stem cells were first produced in 2006 from mouse cells and in 2007 from human cells, by Shinya Yamanaka at Kyoto University , who also won the Nobel Prize in Medicine or Physiology for his work on iPSCs . Yamanaka has ties to Cellular Dynamics International as a member of the scientific advisory board of iPS Academia Japan.
IPS Academia Japan was originally established to manage the patents and technology of Yamanaka’s work, and is now the distributor of several of Cellular Dynamics’ products, including iCell Neurons, iCell Cardiomyocytes, and iCell Endothelial Cells .
Importantly, in 2010 Cellular Dynamics became the first foreign company to be granted rights to use Yamanaka’s iPSC patent portfolio.
Not only has CDI licensed rights to Yamanaka’s patents, but it also has a license to use Otsu, Japan-based Takara Bio’s RetroNectin product, which it uses as a tool to produce its iCell and MyCell products .
Through its licenses and intellectual property, CDI currently uses induced pluripotent stem cells to produce human heart cells (cardiomyocytes), brain cells (neurons), blood vessel cells (endothelial cells), and liver cells (hepatocytes), manufacturing them in high quantity, quality, and purity.
CDI will be an interesting entity to watch within the iPSC product and therapy space because of its relationships with both U.S. researchers and Japanese researchers, including its close partnership with Dr. Yamanaka.
These human cells produced by the company are used for both in vitro and in vivo applications that range from basic and applied research to drug discovery research that includes target identification and validation, toxicity testing, safety and efficacy testing, and more.
As such, CDI has emerged as a global leader with the ability to generate iPSCs that have the potential to be used for a wide range of research and possibly therapeutic purposes.
CDI’s Emphasis on Industrial-Scale Production of iPSCs and Differentiated Cells
In a landmark event with the iPSC market, CDI had an initial public offering (IPO) in July of 2013, in which it sold 38,460,000 shares of common stock to the public at $12.00 per share, to raise proceeds of approximately $43 million . This event secured the company’s position as the global leader in producing high-quality human iPSCs and differentiated cells in industrial quantities.
Furthermore, in March of 2013, Cellular Dynamics International and the Coriell Institute for Medical Research announced receiving multi-million dollars grants from the California Institute for Regenerative Medicine (CIRM) for the creation of iPSC lines from 3,000 healthy and diseased donors, a result that will create the world’s largest human iPSC bank.
Not surprisingly, Cellular Dynamics International has continued its innovation, announcing in February of 2015 that it would be manufacturing cGMP HLA “Superdonor” stem cell lines that will support cellular therapy applications through genetic matching .
Currently, CDI has two HLA superdonor cell lines that provide a partial HLA match to approximately 19% of the population within the U.S., and it aims to expand its master stem cell bank by collecting more donor cell lines that will cover 95% of the U.S. population . The HLA superdonor cell lines were manufactured using blood samples, and used to produce pluripotent iPSC lines, giving the cells the capacity to differentiate into nearly any cell within the human body.
Use of iPSCs in Drug Development and Discovery
CDI also leads the iPSC market in terms of supporting drug development and discovery. For example, CDI’s “MyCell” products are created using custom iPSC reprogramming and differentiation methods, thereby providing biologically relevant human cells from patients with unique disease-associated genotypes and phenotypes . The company’s iCell and MyCell cells can also be adapted to screening platforms and are matched to function with common readout technologies .
CDI’s products are also used for high-throughput screening,  and have been used as supporting data for Investigational New Drug (IND) applications submitted to the Federal Drug Administration (FDA) . While there are other companies participating in this area – including ReproCELL, Cellectis, ArunA Biomedical, and others – competitors are limited and CDI currently leads the way.
CDI’s Acquisition by FUJIFILM Holdings Corporation
Most recently, on March 30, 2015, FUJIFILM Holdings Corporation announced that it was acquiring CDI, in which Fujifilm will acquire CDI through all-cash offer followed by a second step merger. Specifically, Fujifilm is acquiring all issued and outstanding shares of CDI’s common stock for $16.5 per share or approximately $ 307 million, after which CDI will continue to run its operations in Madison, Wisconsin, and Novato, California as a consolidated subsidiary of Fujifilm .
CDI’s technology platform enables the production of high-quality fully functioning iPSCs (and other human cells) on an industrial scale, while Fujifilm has developed highly-biocompatible recombinant peptides that can be shaped into a variety of forms for use as a cellular scaffold in regenerative medicine when used in conjunction with CDI’s products .
Fujifilm has been strengthening its presence in the regenerative medicine field over several years, including by acquiring a majority of shares of Japan Tissue Engineering Co. in December 2014, so while the acquisition was unexpected, it as not fully surprising.
In summary, the acquisition of CDI will allow Fujifilm to gain dominance in the area of iPS cell-based drug discovery services and will position it to strategically combine CDI’s iPS cell technology with Fujifilm’s expertise in material science and engineering systems, creating a powerhouse within the iPSC market.
It is yet to be seen whether Fujifilm will try to commercialize CDI’s iPS cell production technologies by making the cells available for clinical use or whether they will choose to focus their attention on iPS cell-based drug discovery.
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 CellularDynamics.com (2014). About CDI. Available at: http://www.cellulardynamics.com/about/index.html. Web. 1 Apr. 2015.
 Takahashi K, Yamanaka S (August 2006). Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 126 (4): 663–76.
 2012 Nobel Prize in Physiology or Medicine – Press Release”. Nobelprize.org. Nobel Media AB 2013. Web. 7 Feb 2014. Available at: http://www.nobelprize.org/nobel_prizes/medicine/laureates/2012/press.html. Web. 1 Apr. 2015.
 Striklin, D (Jan 13, 2014). Three Companies Banking on Regenerative Medicine. Wall Street Cheat Sheet. Retrieved Feb 1, 2014 from, http://wallstcheatsheet.com/stocks/3-companies-banking-on-regenerative-medicine.html/?a=viewall.
 Striklin, D (2014). Three Companies Banking on Regenerative Medicine. Wall Street Cheat Sheet [Online]. Available at: http://wallstcheatsheet.com/stocks/3-companies-banking-on-regenerative-medicine.html/?a=viewall. Web. 1 Apr. 2015.
 Cellular Dynamics International (July 30, 2013). Cellular Dynamics International Announces Closing of Initial Public Offering [Press Release]. Retrieved from http://www.cellulardynamics.com/news/pr/2013_07_30.html.
 Investors.cellulardynamics.com,. ‘Cellular Dynamics Manufactures Cgmp HLA “Superdonor” Stem Cell Lines To Enable Cell Therapy With Genetic Matching (NASDAQ:ICEL)’. N.p., 2015. Web. 7 Mar. 2015.
 Cellulardynamics.com,. ‘Cellular Dynamics | Mycell Products’. N.p., 2015. Web. 7 Mar. 2015.
 Sirenko, O. et al. ‘Multiparameter In Vitro Assessment Of Compound Effects On Cardiomyocyte Physiology Using Ipsc Cells’.Journal of Biomolecular Screening 18.1 (2012): 39-53. Web. 7 Mar. 2015.
 Sciencedirect.com,. ‘Prevention Of Β-Amyloid Induced Toxicity In Human Ips Cell-Derived Neurons By Inhibition Of Cyclin-Dependent Kinases And Associated Cell Cycle Events’. N.p., 2015. Web. 7 Mar. 2015.
 Sciencedirect.com,. ‘HER2-Targeted Liposomal Doxorubicin Displays Enhanced Anti-Tumorigenic Effects Without Associated Cardiotoxicity’. N.p., 2015. Web. 7 Mar. 2015.
 Cellular Dynamics International, Inc. ‘Fujifilm Holdings To Acquire Cellular Dynamics International, Inc.’. GlobeNewswire News Room. N.p., 2015. Web. 7 Apr. 2015.