Univercell-Biosolutions Launches Center Of Expertise With Industrial And Standardized Approach To hiPSc Cell Line Production

The center of expertise is the first in the world to offer quality control and process management applied to a large panel of standardized products based on the Pluri-one® platform

Toulouse, France, June 24, 2015 – Univercell-Biosolutions, a leading provider of human induced pluripotent stem cells (hiPSC) and hiPS derived product cells for drug discovery, today announces the opening of a center of expertise with an industrial and standardized approach to hiPSC production.

Based on its hiPSC Pluri-one® platform, the company can now offer a wide range of standardized products, services and technology transfer activities. The center of expertise is based in Toulouse at the Pierre Potier Center. It has eight members of staff. The center received a total investment of €3.3M with the support of French state-backed investor BPIFrance and the metropolitan district of Toulouse, who have been supporting the project since 2012.

Univercell-Biosolutions has developed a proprietary industrialized platform and processes that meet high-quality industry standards. The technology has been validated by strict quality control tests that certify a high reproducibility and process stability from batch to batch. Furthermore, Univercell-Biosolutions is the first company to provide an industrial approach to hiPSC production taking into account the requirements of differentiation protocols.

hiPSC is an important raw material that has to be managed under strict quality controls to provide a reliable resource. It is commonly used in medical research for disease modeling, drug development, organ synthesis and tissue repair. These stem cells also have potential in regenerative and transplantation medicine.

The two main groups using hiPSc are:

• Those using the cells as an initial resource in medical research (for the production of neuron, liver, cardiomyocytes…)

• Those working on cell reprogramming who often do not take into account the application potential of their hiPSCs

To bridge the communication gap between these groups, Univercell-Biosolutions’ center of expertise offers a large panel of standardized products based on the Pluri-one® platform. These solutions are specifically designed to integrate end-user requirements and objectives. The Pluri-one® portfolio cell lines have been designed to fit the different culture systems and to integrate the differentiation potential of iPSC.

To fit each differentiation protocol, the Univercell-Biosolutions team has developed four hiPSC culture systems:

• Pluri-one® MEF-C: Clumps of hiPSC adapted to mitomycin MEF culture

• Pluri-one® MEF-CO: Clumps of hiPSC adapted to enzymatic passage and mitomycin MEF culture

• Pluri-one® DM-C: Clumps of hiPSC adapted to qualified matrix culture

• Pluri-one® DM-SC: Single cells of hiPSC adapted to qualified matrix culture

Univercell-Biosolutions’ adaptable platform is able to provide clients with technology transfer, adjusting to specific in-house needs. The company can also assist with platform set up and provide staff with training and regulation of protocols.

“We have decided to define our products and solutions based on customer application requirements and not just on the hiPSC cell pluripotent status,” said Guillaume Costecalde, CEO at Univercell-Biosolutions. “Our center of expertise is now able to provide all our customers with the expertise and the hiPSC cell lines they need to successfully take advantage of this revolution.”

“I wanted to apply my experience in the clinical production of adult stem cells to the induced pluripotent stem cells space. This relatively new industry is not familiar with the strict and proven industrial processes,” said Philippe Bourin, CSO at Univercell-Biosolutions. “With our quality control tests, adaptability and reliability, we have gone one step further in an industrialized hiPSC market.”

Within the past twelve months, the iPSC market has been dramatically accelerated by a series of landmark events. In addition to the first ever clinical trial in humans, the iPSC market recently witnessed a major initial public offering (IPO) for a company specializing in the industrial scale production of iPSCs and differentiated cells derived from them. The substantial grant award will create the world’s largest human iPSC bank and a historic patent challenge that could substantially alter the ability of companies to commercialize iPSC products and technologies without paying expensive licensing fees. http://blog.marketresearch.com/induced-pluripotent-stem-cells-ipsc-3-major-market-forces

The global market for induced pluripotent stem cells (iPSCs) reached an estimated total of $853 million in 2012 and was close to $1.2 billion in 2013, averaging 40% growth. The market is expected to reach $2.9 billion in 2018, an estimated compound annual growth rate (CAGR) of 19.7% for the five-year period 2013 to 2018. The US market was valued at $605 million in 2013 and is expected to reach nearly $1.5 billion by 2018, a CAGR of 19.4% from 2013 to 2018. The Asia-Pacific market was valued at $260 million in 2013 and will experience the fastest growth of all regional markets with a five-year CAGR of 22% to reach $703 million by 2018.

http://www.marketwatch.com/story/induced-pluripotent-stem-cells-global-markets-2014-07-09

About Univercell-Biosolutions S.A.S.

Univercell-Biosolutions S.A.S. is a leading developer of human induced pluripotent stem cells technologies and stem cell-derived products for drug development. The company works with clinicians, academics and industry leaders to develop next-generation homogeneous, mature, functional and differentiated human cells.

Univercell-Biosolutions’ center of expertise, Pluri-one®, is dedicated to hiPSc production. Launched in 2015, the center is based in Toulouse. It has eight members of staff. The company has also developed a revolutionary technique to derive cardiomyocytes from pluripotent stem cells and to select a pure population of cardiomyocytes.

www.univercell-biosolutions.com

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