A company I consulted for was considering licensing a cell therapy from a large, well regarded US research hospital. When we looked at the manufacturing data i

A company I consulted for was considering licensing a cell therapy from a large, well regarded US research hospital. When we looked at the manufacturing data it became apparent that the hospital really had no idea how to characterize the cells they modified and gave to patients. It was basically take cells from a patient, purify them and grow them up in culture, add a few nucleic acids, then readminister. No testing to see if the nucleic acids got into the cells, how many cells got them, whether the cells changed unacceptably during culture, haphazard testing to see if they modified the cell's surface protein levels, no specs as to what level of protein expression were acceptable, etc. They did do safety testing so it isn't likely that the cells would be harmful, but its very likely they would have no effect. There was no malicious intent on the part of the researchers or hospital, they just didn't know how to do commercial quality QA/QC on cell therapies. At the time, no one did. Even so there was some stuff they should have known to do but didnt do This was ~5 years ago so things QA/QC for cell therapy has advanced since then, but its still evolving. Would be interested to know how these hospitals handle this