Lonza has created and made freely available a cost- and time-efficient iPSC manufacturing guide under the FDA’s GMP standard that will help boost the clinical application of regenerative medicines using the cells, and hopefully allow the FDA to approve its first iPSC clinical trial
Human iPSCs are an appealing alternative to ECSs for cell therapies as they do not have the ethical concerns the ESCs raise. However, robust and standardized methods are needed to safely harvest, purify and dedifferentiate cells in order to create the iPSCs, and moreover these processes must be appropriate for large-scale manufacturing, in order for them to be used commercially.
Lonza, a US biotechnology company, have published an open access paper providing a guide for a robust and reproducible GMP-compliant manufacturing process for clinical-grade iPSCs, that should improve the chance of a US iPSC-based clinical trial being approved for the first time.
The paper also announces the availability of master cell banks for iPSCs that are extensively characterized and genetically matched to large segments of the population, so manufacturing can benefit from economies of scale, increasing commercial potential until patient-specific stem cell lines can be generated quickly and cheaply.
As well as provide all the information on this time- and cost-efficient manufacturing process for free, Lonza is selling kits to make the process easier, and will also produce the cells for a fee.
“To our knowledge, no fully cGMP-compliant cell line has been generated where the entire manufacturing process, from tissue sourcing to cell expansion and banking processes as well as documentation, raw materials, staff training, cell therapy facility, and quality control (QC) testing, was validated,” the paper stated.
Co-lead author Mahendra S Rao stated: “We didn’t want Lonza to own the process, even though they helped develop it,” Rao said, speaking on his own behalf. “We wanted the government to be able to provide the process to people, so they could modify it or have access to the process at a reasonable cost. That was one reason why the government funded this … All the basic processes will be free.”
Sources: www.cell.com/stem-cell-reports/abstract/S2213-6711%2815%2900249-0www.cell.com/stem-cell-reports/abstract/S2213-6711%2815%2900249-0; www.sandiegouniontribune.com/news/2015/sep/24/induced-pluripotent-stem-cell-lonza-manufacturing