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Vaccines, Blood & Biologics
From: Fritz, Timothy
Sent: Tuesday, February 22, 2011 12:17 PM
To: Penny Post (email@example.com)
Subject: Clarification regarding CBER's November 12, 2010 Information Request
Dear Dr. Post-
In comment 8f of a November 12, 2010 Information Request (IR) to Protein Science's Corporation (PSC), CBER expressed concern regarding the use of novel antisera and recombinant antigen as reference reagents. This comment noted that the structural integrity of a recombinant hemagglutinin (rHA) should be demonstrated for recalibration purposes, and asked that PSC submit --------------(b)(4)---------------------------------------------------------------- data for these lots.
CBER informed PSC of CBER's preliminary success in recalibrating CBER's X-181 egg-derived reference H1 antigen against PSC's 2009 H1 rHA primary liquid standard in a January 7, 2011 telecon. In the same telecon, CBER requested that PSC provide CBER with PSC's 2009 H1 rHA for lyophilization and evaluation as a potential reference antigen. CBER lyophilized lot ---(b)(4)--- of 2009 H1 rHA provided by PSC.
In a February 15, 2011 telecon, CBER informed PSC of CBER's preliminary success in single radial immunodiffusion (SRID) characterization of the 2009 H1 rHA potential reference antigen. Based upon this success, CBER notes that the structural characterization of PSC's 2009 H1 rHA requested in comment 8 of CBER's November 12, 2010 IR must be provided for lot ---(b)(4)--- of 2009 H1 rHA provided by PSC to CBER for lyophilization. The structural characterization may be conducted on the lot of rHA prior to or after lyophilization. CBER also requests that PSC submit a detailed plan (that includes a comparison with CBER's X-181 recalibrated, approved egg-based reference antigen) to monitor the stability of PSC's potential reference antigen as an amendment to BLA 125285.
If you have any questions, please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-827-3070.
Timothy A. Fritz, Ph.D. Microbiologist FDA/CBER/OVRR/DVRPA/CMC2 WOC1 HFM-478 Suite 371N 1401 Rockville Pike Rockville, MD 20852 Phone: 301-827-3070 Fax: 301-827-1597
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