ProtSeq and GLP/GMP

Giuseppe Raucci (menric@tin.it)
Mon, 01 Mar 1999 11:01:17 +0000

Messages sorted by: [ date ][ thread ][ subject ][ author ]
Next message: Rebecca Ettling: "Misc."
Next in thread: Dave Harding: "AAA problems"

I am in the process of validation of a few methods for the analysis of a
glycoprotein to be used as a drug. It is a recombinant molecule produced
in a CHO cell line and is currently entereng phase II clinical trials.
Among these there are a method of peptide mapping and all the procedures
of automated Edman sequencing.

Since I am coming from an experience of academic type, my knowledge of
validation issues is not complete; besides, I have already seen that
protein sequencing in particular is a tough subject as far as validation
.
Therefore I would very much appreciate any help and indications of good
literature and reference related to these issues.

I will be at ABRF 99 and to the satellite meeting, so that could be a
good occasion to meet if somebody of you all would like to.

Yours truly. Dr. Giuseppe Raucci

Menarini Ricerche-Biotechnology Dept.
Via Tito Speri 10 00040 Pomezia RM Italy
Phone: 39-6-91184434; Fax: 39-6-91601408

Next message: Rebecca Ettling: "Misc."
Next in thread: Dave Harding: "AAA problems"