RE: ProtSeq and GLP/GMP

Freedy, James [OBI] (Jfreedy@obius.jnj.com)
Mon, 1 Mar 1999 08:52:52 -0500

Dear Dr.Giuseppe Raucci,
I am in a similar situation in terms of dealing with the
process of validation. I am also relatively new to the industrial strength
treatment of same. I have to pass along to you and to the group, in terms of
references related to these issues, a group who is very knowledgeable in the
practical aspects and application of validation. I had the opportunity to
work with a group at Amylin Pharmaceutical a while ago and was really
impressed with their efforts and how diligent they were in terms of having
written and implemented various, difficult, "analytical methods" for the
softer, biological type of applications. It is my understanding that they
have formed a new effort Cabrillo Labs which I hope has carried this
expertise with it. My advice in terms of this is to seek out some of our
members who represent Cabrillo Labs or Amylin to learn more. I will also be
attending ABRF 99 and look forward to see you there.
Sincerely,
James G. Freedy

disclaimer: These views are simply my own.

> ----------
> From: Giuseppe Raucci[SMTP:menric@tin.it]
> Sent: Monday, March 01, 1999 6:01 AM
> To: Recipients of ABRF List
> Subject: ProtSeq and GLP/GMP
>
> 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
>