The cells are derived from the H1 human embryonic stem cell line, which was created before August 9, 2001. Studies using this line qualify for U.S. federal research funding, although no federal funding was received for the development of the product or to support the clinical trial.
Geron's H1 hESC master cell bank is fully qualified for human use and was shown to be karyotypically normal and free of measurable contaminants of human or animal origin. Production of GRNOPC1 from undifferentiated hESCs in the master cell bank uses qualified reagents and a standardized protocol developed at Geron over the past three years. Each manufacturing run of GRNOPC1 is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before release for clinical use. GRNOPC1 product that has passed all such specifications and has been released is available for the approved clinical trial. The current production scale can supply product needs through pivotal clinical trials. The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years.
I did not make that up. Any who works with cell lines knows that contamination is a constant problem. There are techniques to reduce contamination, but there are not any full proof methods to prevent it.
“Each manufacturing run of GRNOPC1 is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before release for clinical use. “
They do quality control because there is ALWAYS the potential for cell lines to become contaminated. Again, anyone who works with cell lines knows this.
“The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years.”
This sounds like some sort of PR release from the company. Their claim that they have a 20 year supply is not a scientifically proven fact, it is just a prediction. Notice how they use the words “could potentially supply.”
Remember, this is from a biotech company that wants to sell their product. This does not include any of the original data that was used to make this claim.
Your accusation that “I just made that up” is wrong.