MADISON, Wis., June 21, 2016 /PRNewswire/ -- Cellular Dynamics International, Inc. (CDI), a FUJIFILM company, today announced the appointment of Derek Hei, Ph.D., as Vice President of Clinical Manufacture, Quality, and Regulatory activities to lead efforts in support of manufacturing induced pluripotent stem cell (iPSC)-based products for cell therapies. Dr. Hei has over twenty years of experience developing biotherapeutics from research through clinical trials, most recently as director at Waisman Biomanufacturing, a cGMP-compliant manufacturing facility at the University of Wisconsin-Madison.
- Dr. Hei will direct and manage cGMP-compliant manufacturing processes for production of differentiated and genetically modified cell therapies for clinical trials and cell banking; he will be principally responsible for establishing robust systems for quality control and process validation.
- A recognized leader in the development and manufacture of cell therapies, Dr. Hei has published extensively in the area of developing stem cells and cell-based therapies.
- At Waisman Biomanufacturing, Dr. Hei was responsible for establishing a biotherapeutics and cell therapy contract manufacturing facility from the design and construction stages through to management of all aspects of operations.
- Dr. Hei has extensive experience in preparing for FDA filings and assisting academic institutions, government institutes and global biotechnology and pharmaceutical companies in the IND filing process for cellular, protein, plasmid and viral vector-based therapeutics.
- Dr. Hei has directed research for government funded cell banking and cell therapy development programs and has professional industry experience at Cerus Corporation and Genentech.
- Dr. Hei received a Ph.D. in Biochemical Engineering from the University of California, Berkeley and a B.S. in Chemical Engineering from the University of Wisconsin, Madison.
Emile F. Nuwaysir, Ph.D., CDI President and Chief Operating Officer, said, "CDI has always had the goal of being the global leader in supplying human cells of the highest standards of quality for both research and therapeutic applications. As we anticipate the expansion of the number and variety of cellular therapies that will benefit from CDI's manufacturing capabilities, it is a critical priority for us to maintain the best management team in the stem cell space. With the addition of Dr. Hei's experience, we are well positioned to supply cells that meet the stringent regulatory requirements needed for potential worldwide partners developing cell therapies and therapies based on induced pluripotent stem cell technology."
About Cellular Dynamics International (CDI), a FUJIFILM company
Cellular Dynamics International (CDI), a FUJIFILM company, is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking and cell therapy development. The Company partners with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. CDI's technology offers the potential to create induced pluripotent stem cells (iPSCs) from anyone, starting with a standard blood draw, and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system produces billions of cells daily, resulting in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development. Founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research, Cellular Dynamics is based in Madison, Wisconsin, with a second facility in Novato, California. For more information please visit www.cellulardynamics.com and follow us on Twitter @CellDynamics.
FUJIFILM Holdings Corporation, Tokyo, Japan brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.
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SOURCE Cellular Dynamics International (CDI), a FUJIFILM company