Ann: CYP to Present at Major International Stem Cell Conference, page-2

From the Roberts report ...I wonder how long before they announce they have successfully completed scale-up ....

Cynata is current working on industrial-scale production of its stem cells

 The ability to make stem cells under GMP at scale is paramount going forward. GMP is Good Manufacturing Practice, the set of standards that have been laid down by regulators such as the FDA for the production of clinical-grade pharmaceuticals. A key challenge the stem cell sector faces at the moment is making stem cells under GMP. The drug that is given to patients has to be safe, reproducible and efficient. The starting material needs to be defined. The level of cell density in culture needs to be known. The medium used has to be worked out, and preferably it needs to be ‘serum free’, that is, avoid the use of fetal bovine serum. Finally, analytical methods are needed so that the phenotype, functional potential and microbiological safety of the product is consistent, and that cultured cells remain untransformed.

 We regard scale-up as critical to value creation at Cynata. If the company can show that it can make its cells at industrial scale under GMP then it will be in a position to be a genuine Stem Cell Revolutionary, combining the known therapeutic power of MSCs with the low cost of iPS cells. This will suggest to potential commercial partners that they can work with Cynata without having to worry about GMP issues. We understand that the scale-up process is going well and that the manufacturing process is serum-free63. The decision to go with Waisman Biomanufacturing on scale-up is, in our opinion, a good one because the company gets access, either directly or indirectly, to the all the stem cell expertise that has congregated in Madison over the last 15 years, including the folks at Cellular Dynamics64.


 There are various tricks that the Waisman people can use to get maximum yield from iPS cells, such as choice of media (both basal and supplementary), cell seeding density, the culture flasks used and the physiochemical environment within the flasks (which involves such variables as dissolved oxygen and carbon dioxide concentrations, temperature, pH, osmolality, and the buffer system). Given this array of tools, scale-up is an engineering process rather than a scientific breakthrough in the making