Yesterday, Stem Cell Reports published must read paper, which describes manufacturing of GMP-grade iPS cell line for potential clinical use. We saw a few very similar paper titles in in the past, but this one is special. Here is why:

We didnt 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.

I have few general consideration about this protocol and few technical. Lets start from general: Since, Im as US taxpayer also funded this study, Id like to have an option for process tech transfer to my facility. If not Lonza, who is owner of this process? Can I get a license and do the same thing in-house? The process largerly developed on Lonzas reagents and platforms (such as nucleofection). Also, proprietary reagent and process were mentioned in the paper. Id be ok to buy Lonzas reagents for this wonderful process, but what if Id like alternative to reduce the cost? Also, in GMP must be back-up supplier for every reagent and material. Who is back-up for Lonza?

Now, some technical considerations:

Overall, I was enjoying reading this paper. Id highly recommend this protocol to every cell product developer, irrespective to type of your cells!

Tagged as: clinical protocols, donor eligibility, drug master file, GMP, iPS, iPS cell bank, manufacturing, master cell bank, protocol, QC

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A protocol for manufacturing of GMP-compliant iPS cell lines

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