Replies to post #6626 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>…FDA insistence that the protein sold must be made, eg by cell culture, by the same method of the protein that was created for the trials.<

This is an important point—companies that want to employ GTC’s production platform have to sign on early in the development timeline, as Merrimack did with MM-093.

>If it is made by a different technique, eg transgenics the FDA would consider it a different drug which would have to go thru a completely new set of trials.<

I would agree if you omitted the word completely. The premise of FoB’s is that characterization and in vitro analysis will enable some reduction in clinical testing, the amount of reduction being determined on a case by case basis.

[DewDiligence]

>It may well be better for GTCB (the shining star of NPPS companies) to partner with a company like DuPont or Monsanto who are one step away from big pharma.<

Such companies as DuPont and Monsanto, who have only historical connections to the pharmaceutical business, would not be the best choices for GTC to partner with, IMO.

[gym gravity]

kidding, a bit. but they are into production through GE healthcare and Vaccine production with cell culture (NVAX)

I can't remember how I answered the quiz. I was very focused on why they haven't dropped the G and the C from the name to become transgenic biotherapeutics or somehting. Why not Kirin?