The article mentions GTCB, not sure that they identify others working on same proteins..lets see..
They only provide abstracts online but let me give you the gist of it .
-Challenging science, not regulation, is the real hurdle to success.
According to Frost and Sullivan, the US market for trangenics-made pharmaceuticals (TMP) could reach 2.2B by 2011.
Article says that, traditionally, regulations were the main roadbloack to TMP but that view may be simplistic as scientific issues keep popping up.
Some say Edible plants remain an attractive route to TMPs since crude feedstocks are safe and probably edible:
NuCycle Therapy= plant-based production of insulin, Mabs, human growth homrone in petunia [!]. Also developing an oral vaccine...According to the CEO, plant-based TMP produces similar concentration of proteins to transfected systems but take less time to develop.
From their point of view, even if the viruses get into the plant or process, there is nothing for them to replicate on...
Biolex which has a bioreactor that uses plant lines and a main product in development in phase1 in UK (alfa interferon);and also in collaboration with Medarex on a monoclonal antibody.
-Mentions Greenovation that has a bioreactor to generate proteins.
- Cardinal Health, relied on Transgenic cattle but made a transition to cell lines given the industry's desire to remove all animal-derived products from manufacturing processes and the dramatic improvements being made in cell culture productivity... "These factors are slowing the interest in transgenic animals as a production alternative (...) as protein purification is generally easier from serum-protein free cell cuture media than from milk" (...) "the benefic of trangenics is in cost-of-goods, the ability to scale up by breeding animals instead of building bioreactors (...) what we are seeing now is that cell lines are becoming more and more productive as trangenics were four or five years ago; there is still a role for trangenics but it is being pushed out further in terms of scale" (...)"the transgenic approach is more viable for commodity nutraceutical-type products where hundreds or thousands of kilograms are needed per year".
GTCB focuses on replacement therapeutic proteins rather than discovery molecules; they avoid direct comparisons between cell cultures and transgenics as "the best candidates for transgenics are proteins that do not express well in bioreactors (...)capacity buildup is about three to five years with animals, this is exactly the same as for bioreactors". The use of cloning makes the process faster.
BioProtein Technologies works on rabbit milk which, according to the CEO, offers the best compromise between easy-to-develop mouse trangenics and large-scale cattle systems. Offsprings are generated within a few weeks.
In the end, the key question regulators will probably focus on is product consistency and quality measures to ensure that viruses and other agents either dont arise or are removed or inactivated.
Pretty positive overall..
