Stem Cells
Generation of stem cells from bone marrow
potency as the cells from well characterised cell banks. Many companies are working on new bio- material scaffolds, bioreactors and bioprocess sys- tems to meet the needs of producing large numbers of well-characterised stem cells. These companies include EMD Millipore, BD Biosciences, ATMI and Xcellerex.
In many ways, the level of complexity for cell products is higher than for biologics. The need to supply a large number of highly characterised and documented cells exists on an international basis. Medical tourism is increasing; patients are seeking treatments for life threatening diseases that are cur- rently not approved for sale in the US. In addition, there is a need for the many cells that are being administered under approved experimental clinical trials internationally.
(bone cells) or adipocytes (fat cells), making them ideal candidates for tissue engineering. MSCs can contribute to the regeneration of bone, cartilage, muscle and tendons. It has also been shown that, when transplanted systemically into animals, they are able to migrate to the sites of the injury. Scientists are currently examining the potential of generating healthy heart muscle cells in the labora- tory and then transplanting those same cells into patients with chronic heart disease.
While progress in this area is exciting, more work remains in both process and clinical develop- ment. One of the critical factors limiting growth of the cell-based therapy industry is the lack of expertise in product development and specialised manufacturing that will be required to bring these products to market. Challenges include achieving high cell densities, control of cell differentiation and production of uniform cell populations, which maintain the desired phenotype and function. Small scale suspension culture systems for undif- ferentiated hESC and iPSCs have been developed and offer an approach for large-scale propagation of undifferentiated pluripotent cells for clinical and translational applications. This work requires the systematic study of relationships between cell char- acteristics, cell density, oxygen, and cell function. Lovett, et al (Tissue Engineering Part C: Methods. December 2010) reported changes in the expres- sion profiles of hMSCs differentiated under varied oxygen tensions and showed different tissue-specif-
ic oxygen requirements for adipogenic (20% O2) and chondrogenic (5% O2) differentiation. In addition to process control strategies, expansion of
attachment dependent cells, such as MSCs, offer additional challenges. Expanded cells must main- tain a desired phenotype and have the functional
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This is a perfect niche for contract manufactur- ing companies to support development and clinical supply for regenerative medicine companies. Companies such as Lonza, Progenitor and Paragon Bioservices, Inc all offer contract services to drug and regenerative medicine companies. Use of out- sourced suppliers for stem cell products fits with current pharmaceutical company strategy to focus internal resources on core capabilities and out- source pre-clinical and clinical stage manufactur- ing. Recognising all of the potential in the field of stem cell therapies and the possibility of finding solutions for public health imperatives, Paragon Bioservices, Inc and the University of Maryland’s Center for Stem Cell Biology and Regenerative Medicine recently created a stem cell initiative to explore how they could advance the scientific research in this exciting field. This public-private partnership is for the development and manufac- turing of stem cell therapies. The Stem Cell Technology Consortium is openly seeking wider participation from multiple universities, State and Federal agencies, and private companies. DDW
Dr Aaron H. Heifetz supports Paragon’s expanding business segments in cell therapy, stem cells and regenerative medicine. Aaron has 20 years of indus- trial management experience within biomedical/ biotechnology businesses with process and product development, manufacturing and commercialisation responsibilities. He was Vice-President, Business Development at Cognate Bioservices, a manufacturer of cell therapy products and was Vice-President, General Manager and Site Director of Cambrex Bio Science Baltimore, a contract developer and manu- facturer of biologics and vaccines.
Drug Discovery World Fall 2011
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