
3/9/2008 Email - Rotarix

 

 
From: Henchal, Laraine 

Sent: Sunday, March 09, 2008 6:02 PM 

To: 'Donna.2.Boyce@gsk.com' 

Cc: Vujcic, Luba 

Subject: ------------ used to establish ---------- Vero Working bank 

Hi Donna,

One more question similar to the one I had about the ---------------. You tested the original Master cell bank for ------ and ------- viruses in a culture assay with specific testing for ---- and ------------------ testing. That is OK as it covers the agents of most concern. Then, when you made the ---------- bank, you had --- passage in ----- (--------- origin), but then did NO followup ------------ testing on the Working or EOP banks. Was the ----- tested for any ------ agents by --- -------do you have original CoA?

Laraine S. Henchal, MAS
 Microbiologist Reviewer, Team Leader
 Viral Vaccines Branch
 Division of Vaccines and
 Related Products Applications
 Office of Vaccines Research and Review
 Center for Biologics Evaluation and Research
 Food and Drug Administration
 Phone: 301-827-3070
 Fax: 301-827-3532
