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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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9/18/2007 Email - XYNTHA

From: Kearns, Daniel
Sent: Tuesday, September 18, 2007 11:29 AM
To: Lee, Timothy; Renshaw, Carolyn
Cc: Trout, Deborah; Cottrell, Pauline; Stephenson, Franklin
Subject: Memo of Telecon Wyeth 125264-0


DATE:   Tuesday, September 18, 2007 at about 11:05 am
FROM:   Daniel Kearns, HFM-675
TO:   D. Gates, Wyeth representative
SUBJECT:   Bioburden results pre or post filtration; shared equipment at ------------------------- cell testing

I (DK) called and spoke to D. Gates, the Wyeth representative for CMC issues for STN 125264. I said that there were 3 points for which some clarification were needed:

1.   In section 3.2.S.2.5 (see table 3-3 for example) all the bioburden results are 0 (zero) - we wanted to determine if that represents sampling prior to filtration
2.   With regard to ---------------------------------, and what appears to be shared equipment with highly potent compounds, clarification as to what compounds and what equipment is shared, and the cleaning specifications (e.g., 1/1000th of a therapeutic dose)
3.   Are each lot of ----------------- cells tested for ---------- (Mr. Gates responded that they are, and each ----------------- lot is tested in full (----------------------------- - I asked for the reference and he will supply).

Mr. Gates said he would get the information to me as soon as possible. The conversation concluded.

Prepared by D.Kearns on Tuesday, September 18, 2007 at about 11:30 am