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Dominance of Cellular Dynamics International (CDI) within iPSC Marketplace

Cade Hildreth (CEO)

Cellular Dynamics International (CDI), a FUJIFILM company, is the largest provider of induced pluripotent stem cell (iPSC) products worldwide. iPSCs are a type of laboratory made stem cell that has significant potential for use within regenerative medicine.

Theoretically, iPSCs have the potential to treat a wide range of diseases, including diabetes, heart diseases, autoimmune diseases, neural decline and more. iPSCs are also being widely implemented for use in drug development and discovery, as well as toxicology screening and personalized medicine.

In this article:

Cellular Dynamics International and iPSC Therapy

Since September 2016, Cellular Dynamics International (CDI) has been divided into two business units, a Therapeutics Business Unit and a Life Science business unit. CDI’s Therapeutics business unit is focused on developing induced pluripotent stem cell (iPSC) based therapies for ocular, cardiac, neural and oncology applications. In contrast, CDI’s Life Science business unit is focused on developing the research products side of the business.

iPSC Market Competitors

In addition to CDI, there are many other companies and organizations that are involved with the development of induced pluripotent stem cell (iPSC) therapies, including but not limited to:

There are also a number of companies specializing in iPSC product development, including:

Fujifilm Cellular Dynamics Inc

Cellular Dynamics International is one of the most important market participants in the iPSC sector, because of its dominance in both iPSC therapies and life science tools.

Cellular Dynamics International, Owned by FujiFilm Holdings


Headquartered in Madison, Wisconsin, Cellular Dynamics International (CDI) 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 900 patents, of which 130 pertain to iPSCs.

In April 2015, the company was acquired by FujiFilm Holdings Corporation, strengthening both  financial and strategic footholds within the industry.

Cellular Dynamics Fujifilm’s Role in the iPSC Market

According to the company, CDI is the world’s largest producer of functional human cells derived from iPSCs.[1] Its 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 [2].

To date, CDI’s main role with regard to iPCS therapy development has been the production of industrial-scale, clinical-grade iPSCs.

Cellular Dynamics and Shinya Yamanaka

Induced pluripotent stem cells were first produced in 2006 from mouse cells and in 2007 from human cells, by Shinya Yamanaka at Kyoto University [3], who also won the Nobel Prize in Medicine or Physiology for his work on iPSCs [4].

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 [5].

CDI’s Rights to the Yamanaka Patents

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 [6].

CDI’s Induced Pluripotent Stem Cell Differentiation

Through its licenses and intellectual property, CDI currently uses induced pluripotent stem cells to produce:

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.

Human Stem Cell Products for Drug Discovery

The human cells produced by CDI 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 a result of its ever expanding iPSC product portfolio, 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.

Cellular Dynamics International Stock Share Prices

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 [7].  This event secured the company’s position as the global leader in producing high-quality human iPSCs and differentiated cells in industrial quantities.

Cellular Dynamics California Fund Grant from CIRM

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 further continued its innovation, announcing in February of 2015 that it would be manufacturing cGMP HLA “Superdonor” stem cell lines to support cellular therapy applications through genetic matching [8].

Blood Samples for the HLA Superdonor Research

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 [9].  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 [10].

The company’s iCell and MyCell cells can also be adapted to screening platforms and are matched to function with common readout technologies [11].

Leading Role in High-Throughput Screening and IND

CDI’s products are also used for high-throughput screening, [12] and have been used as supporting data for Investigational New Drug (IND) applications submitted to the Federal Drug Administration (FDA) [13]. 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

As mentioned above, on March 30, 2015, FUJIFILM Holdings Corporation announced that it was acquiring CDI through all-cash offer followed by a second step merger. Specifically, Fujifilm acquired all issued and outstanding shares of CDI’s common stock for $16.5 per share or approximately $307 million.

Following the change in ownership, CDI has continued to run its operations in Madison, Wisconsin, and Novato, California as a consolidated subsidiary of Fujifilm [14].

Fujifilm in the Field of Regenerative Medicine

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.

The acquisition of CDI has allowed Fujifilm to gain further dominance in the area of iPS cell-based drug discovery services and has positioned it to combine CDI’s iPS cell technology with Fujifilm’s expertise in material science and engineering systems.

Where Will CDI Focus iPSC Cell Production Technology?

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.

Where do you think CDI will focus its iPSC technology? In your opinion, which direction will further advance the company’s role in stem cell research? Share your thoughts in the comments below.

Up Next: Interview With Kaz Hirao, CEO Of Cellular Dynamics International (CDI)

Footnotes
[1] CellularDynamics.com (2014). About CDI. Available at: http://www.cellulardynamics.com/about/index.html. Web. 1 Apr. 2015.
[2] Ibid.
[3] 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.
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8]  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.
[9] Ibid.
[10] Cellulardynamics.com,. ‘Cellular Dynamics | Mycell Products’. N.p., 2015. Web. 7 Mar. 2015.
[11] 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.
[12] 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.
[13]  Sciencedirect.com,. ‘HER2-Targeted Liposomal Doxorubicin Displays Enhanced Anti-Tumorigenic Effects Without Associated Cardiotoxicity’. N.p., 2015. Web. 7 Mar. 2015.
[14] Cellular Dynamics International, Inc. ‘Fujifilm Holdings To Acquire Cellular Dynamics International, Inc.’. GlobeNewswire News Room. N.p., 2015. Web. 7 Apr. 2015.

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