Well, apparently I didn't make myself clear enough. I'll try using shorter words.
Simple doesn't mean cheap. Hope that was clear. Purification costs are typically 2/3 of the COG for a biopharmaceutical. Oh crap, I used more jargon. Scientists in biochemistry labs., such as myself, may be brilliant and admirable, which apparently I'm not, but often they don't consider regulatory and industrial requirements when devising new protein production systems. Maybe they have indeed thought about it in this case, and hence the article's discussion of a 5 year wait which I was partially explaining after others expressed surprise. And trust me on the post translational modifications, they will be different. Maybe this is the wrong forum to be discussing this technology.
A few problems that will cause this idea to take several years to, er, hatch...
Genetically engineered animals and plants have been used to make therapeutic proteins before (but not commercially yet, AFAIK). However, a good fraction of the cost in making such proteins is the purification, not the initial production. Animals, plants, eggs, milk all have to be purified before a therapeutic drug is usable and the costs there are more like phoenix feed. [Such drugs have to be injected, you can't eat the egg etc., the protein would simply be digested in the stomach].
In this age of avian influenza, we'd have to develop ways to test for avian viruses and a way to test for residual egg proteins in the purified drug. Some people are allergic to eggs you know... So that's 2-4 years right there. Plus you have to convince regulatory authorities (FDA) that you've got a valid set of such tests.
And would such proteins be good drugs even if pure? What would be the post-translational modifications? Ooh look, a link. http://en.wikipedia.org/wiki/Post-translational_mo dification Birds don't do things quite like humans do, so the non-protein parts of the drug (glycosylation, phosphorylation etc.) would be different from human proteins. Would these mods. create an allergic reaction even if all egg proteins had been removed? Would they have the same or suitable pharmacokinetics (how a drug moves around and out of the body)? If not, what clinical trials would be needed to find the answers?
Similar questions have been answered over the years for proteins made in cell culture and by microbial fermentation. Eggs got some catching up to do. Possible, but expensive and a long process.
Mind you, it would be fun developing an industrial egg cracker. Nah, they probably already exist in the food industry. Insert Humpty Dumpty joke.
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Well, apparently I didn't make myself clear enough. I'll try using shorter words.
Simple doesn't mean cheap.
Hope that was clear. Purification costs are typically 2/3 of the COG for a biopharmaceutical. Oh crap, I used more jargon. Scientists in biochemistry labs., such as myself, may be brilliant and admirable, which apparently I'm not, but often they don't consider regulatory and industrial requirements when devising new protein production systems. Maybe they have indeed thought about it in this case, and hence the article's discussion of a 5 year wait which I was partially explaining after others expressed surprise. And trust me on the post translational modifications, they will be different. Maybe this is the wrong forum to be discussing this technology.
A few problems that will cause this idea to take several years to, er, hatch...
o dification Birds don't do things quite like humans do, so the non-protein parts of the drug (glycosylation, phosphorylation etc.) would be different from human proteins. Would these mods. create an allergic reaction even if all egg proteins had been removed? Would they have the same or suitable pharmacokinetics (how a drug moves around and out of the body)? If not, what clinical trials would be needed to find the answers?
Genetically engineered animals and plants have been used to make therapeutic proteins before (but not commercially yet, AFAIK). However, a good fraction of the cost in making such proteins is the purification, not the initial production. Animals, plants, eggs, milk all have to be purified before a therapeutic drug is usable and the costs there are more like phoenix feed. [Such drugs have to be injected, you can't eat the egg etc., the protein would simply be digested in the stomach].
In this age of avian influenza, we'd have to develop ways to test for avian viruses and a way to test for residual egg proteins in the purified drug. Some people are allergic to eggs you know... So that's 2-4 years right there. Plus you have to convince regulatory authorities (FDA) that you've got a valid set of such tests.
And would such proteins be good drugs even if pure? What would be the post-translational modifications? Ooh look, a link. http://en.wikipedia.org/wiki/Post-translational_m
Similar questions have been answered over the years for proteins made in cell culture and by microbial fermentation. Eggs got some catching up to do. Possible, but expensive and a long process.
Mind you, it would be fun developing an industrial egg cracker. Nah, they probably already exist in the food industry. Insert Humpty Dumpty joke.