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Vaccines, Blood & Biologics

3/9/2008 Email - Rotarix

From: Henchal, Laraine

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

To: ''

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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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