Re: GLP/GMP

Ross Durland (durlar@genemedicine.com)
Fri, 6 Nov 1998 17:23:25 -0600

I think that's very likely to be an approvable process, in principle. The
key is ensuring (& documenting) that your provider of native bovine enzyme
uses *only* cattle from a safe country. Currently, I think that includes
the US, Canada, & New Zealand, & maybe some others. Someone at FDA (or
perhaps some document available from their website) could tell you.

Paul Tressel <pault@allelix.com> on 11/06/98 10:23:38 AM

To: Recipients of ABRF List <abrf@aecom.yu.edu>
cc: (bcc: Ross Durland/GeneMedicine)
Subject: GLP/GMP

Would FDA approve the following process?
An immobilized native bovine enzyme is used to release a drug from its
recombinant construct. The drug is then passed through a 5,000 MW
cellulose triacetate membrane (the drug could be mixed with a 10,000
dalton fluorophore as a QC/QA test of the membrane integrity, prions
having >23kD molecular weight). Would this solve the problem of
requiring the immobilized native bovine enzyme to be absolutely free of
TSEs(multiple ultrafiltration membranes could be used for added
insurance)? The reason for even asking this question is that "native
bovine enzyme" is not only much less expensive than the recombinant
form, but is also enzymatically superior.