Steve,
Thanks for the response on plant transgenics. Have to agree that plant transgenics is currently years behind animal transgenics, but will plants be able to make that up with shorter lead times to production vehicles?
Agree that glycosylation can be done after the fact, but expensively. Does this suggest that Cerezyme might be made more economically via pharming?
>>It is not clear at this point that plants can ever be made to meet FDA's manufacturing standards. We already know that transgenic animals can meet these standards.<<
Interesting you should mention that... After our discussion on PPL's timeline to approval, I found an interesting comment from Eva Sandberg of the Danish Medicines Agency on this very subject (Nature Biotechnology, July '97 (15:7), p. 602 - sorry, no online version). According to Biotechnology, Dr. Sandberg declared that pharming is NOT from a regulatory point of view, going to be the most rapid route to the market. She added that in assessing new biological drugs, production in yeast or bacteria is preferred over production in mammalian cells, and that with transgenic animals there is "always an additional risk of failure of good manufacturing practice." Admittedly, Dr Sandberg, as head of the microbiology department at the DMA, may be a little biased, but her remarks were at the European Society of Regulatory Affairs. What do you think?
At least we now have an official declaration that it is "pharming," not ranching.
BTW, Congrats on the AT-III collaboration (both sides).
biowa |
