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Biotech / Medical : Bioterrorism
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To: Biomaven who wrote (171)10/10/2001 5:27:20 PM
From: scaram(o)uche   of 891
 
comments from a friend.......

I see the following challenges:

Production Cost: the numbers I have seen put chicken eggs a bit lower in
cost than goats or cows for raw production. But these costs are not
necessarily inclusive of the capital and operating costs for facilities
that
would be required for alignment with GMP harvesting and purification. Many........... we have talked to are considering chickens, but
are skeptical based on experiences with goats (see GZTC mkt cap).

Purification Cost: Protein A affinity purification is not the low cost
leader for antibodies, although it is the industry standard today. Lower
cost methods will be required for much gain in overall purification cost.
Whether IgY binds to protein A with high affinity or not, there will need
to
be stringent proof that no Igs from chicks appear in the purified product.
Most of the steps used today prior to [immunoglobulin] purification will not
effectively separate IgY from human Ig fractions. Therefore the affinity
purification step is absolutely critical. The purification will also be
very complicated if the yolk is not completely avoided. The yolk-derived
lipid fraction is expensive to remove and if not, will foul almost any
column material. Protein A columns of significant size are a couple of
million bucks.

Regulatory: Egg-derived antibodies will probably have similar viral,
zoonotic, and prion testing and purification requirements to transgenic
animals and cell culture fermentation. The standards for flock (or herd?)
management related to infectious agent control will be very challenging.
The
Europeans have taken a fairly strong stand against any transgenic
animal-derived products for these reasons.

Husbandry risk: A variety of diseases, while of limited threat to humans,
can wipe out an egg operation fairly quickly. A similar problem exists for
herd animals, but is magnified in high density poultry operations.
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