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Vaccines, Blood & Biologics

Record of Telephone Conversation, January 7, 2011 - Flublok


Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product: Influenza Vaccine
Applicant: Protein Sciences Corporation
Telecon Date/Time: 07-Jan-2011 12:30 PM        Initiated by FDA? Yes
Telephone Number: —b(4)----------
Communication Categorie(s):
1. Advice
2. Other - Update on CBER reference antigen recalibration
Telecon Summary: CBER comments on (b)(4) protocol submitted and CBER reference antigen recalibration.
FDA Participants:
Maryna Eichelberger
Arifa Khan
Jerry Weir
Rakesh Pandey
Helen Gemignani
Timothy Fritz
Non-FDA Participants:
Penny Post
Manon Cox
Joe Rininger
Yoshi Hashimoto
Kathryn Rizzo
Rick Chubet
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
CBER explained that the purpose of the telecon was to determine whether PSC had additional questions regarding CBER’s December 10, 2010 request for protocols from PSC for –b(4)---------------------- and hemagglutination inhibition (HAI) testing. CBER noted that it would not discuss the HAI results submitted by PSC on January 5, 2011 since additional time was needed by CBER to review the data. However, CBER said that it could provide PSC with an update on preliminary results of CBER’s efforts to recalibrate CBER’s reference antigen against PSC’s primary liquid standard and would provide comments on the b(4) protocol submitted by PSC on January 5, 2011.
CBER reference antigen recalibration
CBER said that the initial results of recalibrating CBER’s X-181 H1 egg-derived reference antigen were encouraging.  Lot –b(4)----- of PSC’s recombinant H1 (rH1) was used as a primary liquid standard (PLS) after determining HA concentration by measuring total protein concentration and purity by –b(4)------------. Single radial immunodiffusion (SRID) assays using the PLS resulted in faint rings, but CBER noted that this was not unexpected. CBER said that additional tests would be conducted in the next few weeks and once there was confidence that the PLS could be used, recalibrated reagents (CBER egg-derived HA and sheep antiserum) would be provided to PSC.  CBER said that it would be best to use homologous antigen as the reference antigen for SRID assays. Therefore, CBER requested that PSC send CBER 30-50 mg of PSC’s 2009 rH1 for CBER to lyophilize and evaluate as a reference antigen. CBER said that the rH1 did not need to be from one of the lots already provided to CBER.
PSC asked whether they still needed to obtain live virus for HAI assays to assess antigenic relatedness. CBER replied that the initial HAI test results suggested that live virus may not be needed but that CBER needed to review PSC’s data further before reaching a final decision.
PSC asked if the total protein and purity results obtained by CBER were similar to the values obtained by PSC. CBER said yes.
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1 page determined to be not releasable: b(4)

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