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Vaccines, Blood & Biologics
From: Fritz, Timothy
Sent: Thursday, May 05, 2011 4:38 PM
To: 'Penny Post (firstname.lastname@example.org)'
Subject: CBER clarification of April 27, 2011 telecon regarding H1 rHA SRID assay
Dear Dr. Post-
In an April 27, 2011 telecon, CBER indicated that Protein Sciences Corporation (PSC) should evaluate whether the SRID assay using the potential 2009 H1 rHA reference antigen is stability indicating. CBER wishes to clarify that PSC has CBER approval to use the revised SRID assay conditions (--b(4)-------------------------------------------------and lyophilized 2009 H1 rHA as reference antigen) provided the SRID assay is indicative of stability. Therefore, PSC should provide CBER with data to demonstrate the revised SRID assay is stability indicating.
CBER recommends that PSC measure the potency of trivalent vaccine (formulated to contain 2009 H1N1) stored at 4°C and vaccine stored under conditions specified in your accelerated stability protocol. In addition, PSC should measure the potency of trivalent vaccine that has been purposely stressed/denatured using heat, pH or chemical treatment. Please provide the potency results for each antigen in the vaccine (H1, H3 and B) under these conditions at t=0, and a time point expected to decrease potency under accelerated conditions. Also provide total protein concentration to demonstrate consistent amounts of protein have been assayed.
Please submit the requested information as an amendment to your Biologics License Application STN 125285. If you have any questions, please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-796-2640.
Timothy A. Fritz, Ph.D. Microbiologist FDA/CBER/OVRR/DVRPA/CMC2 WOC2 HFM-4781451 Rockville Pike Rockville, MD 20852 Phone: 301-796-2640 Fax: 301-827-1597
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