GLP/GMP -Reply
Henry Wolfe (hnwo@americas.nycomed.com)
Mon, 09 Nov 1998 06:17:18 -0700
I doubt whether such a simple in vitro surrogate test for prion/TSE
removal would be adequate and am certain that an animal model
analogous to those used for viral validation studies would be required.
The immobilization is an irrelevant aspect, with greater emphasis being
on the source of bovine material. A closed herd proven to be TSE/prion
free would go a long way. Additionally, if you can validate TSE/prion
removal and demonstrate control of your process, they should have no
particular prejudice against it.
Hank Wolfe
Nycomed Amersham (USA)
Wayne, Pa