Off the shelf cell therapies – what could go wrong?,or.r_qf.&bvm=bv.50500085,d.dmg&biw=1280&bih=885&um=1&ie=UTF-8&hl=en&tbm=isch&source=og&sa=N&tab=wi&ei=mu0EUpKNFuSQyAG9hoCgBg#facrc=_&imgdii=_&   cryopreservation

This was a while back but I cannot help bringing it up again as cryopreservation is basic to the development of cell therapies – the future for unmet medical need:

"What is lost or gained with cryopreservation that could give an advantage/disadvantage to minimally manipulated cells (and an argument for regulation of SCs as drugs)?"

Two things came to mind as I was reading through this linked-in conversation; the Dendreon case, and friends who have built their businesses around cryopreservation.

In a few words and in my layman understanding, wasn't part of Dendreon's failure due to "lack of preservation" while in transit; not exactly the 25-year cryopreservation discussed in linked-in but a related issue, I feel.

And yes "people have received transplants of cryo-preserved bone marrow for over 50 years and so far no problems" but I wonder how Thermofisher, Sigma Aldrich, Invitrogen, Cryoport… the cryopreservation providers are reacting to this query?

On the advantages/disadvantages of regulating SCs as drugs… no wonder more and more companies are headed to Mexico, or that stem cell companies are setting up shops in the Bahamas while the US is still figuring out safety and efficacy.

We've organized stem cell conferences in the US for the last 5 years and no other time than now has it become more exciting. There is so much that hangs in the air and once a year we provide this platform where biotechs come together with the FDA, solution and technology providers, and a few investors to discuss face-to-face and clear out issues as much as we can but more so to find collaborators.

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  1. Pingback: Off the shelf cell therapies – what could go wrong? | TransBio-Tex

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