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Vaccines, Blood & Biologics

Record of Telephone Conversation, November 26, 2012 - Q-Pan

Submission Type: BLA

Submission ID: 125419/0

Office: OVRR

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

ID Biomedical Corporation of Quebec

Telecon Date/Time: 26-Nov-2012 02:21 PM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request


Telecon Summary:
Information request about the H5N1 antigen at the Ste. Foy facility and the AS03 at the Rixensart/Wavre facilities

FDA Participants: Jeremy Wally, Kirk Prutzman, Carmen Collazo

Non-FDA Participants: Michael Schwartz, Robert Brobst, Jillian Horvath

Telecon Body:
The following was communicated to GSK via e-mail correspondence.

From: Collazo, Carmen
Sent: Monday, November 26, 2012 2:21 PM
To: Michael Schwartz; Robert Brobst; Jillian Horvath
Cc: Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject: STN 125419 - Information Request

Dear Dr. Schwartz,

Please provide additional information for the following items:

Regarding the H5N1 antigen at the Ste. Foy facility:

  1. You state that the filtered and sterile H5N1 antigen monovalent (b)(4) is stored in --------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------. We have the following comments:
    1. Please indicate whether -------(b)(4)----- are used for storage of the seasonal flu vaccine and whether you have submitted qualification for ----(b)(4)--------------- to CBER in association with other U.S.-licensed products. Please provide the necessary information to support your answer.
    2. Please clarify where in the BLA submission you provided the reports to support container closure integrity testing and aseptic media simulation using -(b)(4)-.
    3. For the media simulation/aseptic formulation process, please provide the sampling procedure and the number of samples and/or containers incubated to demonstrate “no microbial growth.”
  2. For the preservative effectiveness studies performed on Quebec H5N1 drug product developmental lots, you provided data for "selected lots" in Tables 4-9 in eCTD section Antigens P.2.5 Pharmaceutical Development. Please clarify if these results are representative of all lots tested.
  3. For the Qualification for the Filling and Stoppering Machine --(b)(4)--, please provide the number of runs, number of vials and stoppers, interventions/planned deviations, product filled and the number of vials for the re-executed test. Please indicate the low and high speed levels tested.
  4. For the Qualification of the GMP Autoclave –(b)(4)--- for stoppers and filling machine loads:
    1. Please provide the number and location of (b)(4) in the heat distribution study.
    2. Please provide the location of (b)(4) in the loads and indicate whether they were in fixed location throughout the (b)(4) runs performed of maximum and minimum loads.
    3. Please provide diagrams to show the minimum/maximum loads for the filling machine.
    4. Please clarify what you mean by flexible loads (i.e., are they fixed/defined loads or are they undefined loads?).

    Regarding the AS03 at the Rixensart/Wavre facilities:

  5. Please clarify when the (b)(4) were installed in the formulation and filling areas. Also, please indicate in which section in the BLA submission is the information for the (b)(4) qualification for the filling area.


Carmen M. Collazo-Custodio, Ph.D.
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

Office location:
1451 Rockville Pike Rm. 2236
Rockville, MD 20852
Tel. 301-796-2640
Fax: 301-827-3532
E-mail address:

Mailing address:
Center for Biologics Evaluation and Research
Document Control Center HFM-481
1401 Rockville Pike
Rockville, MD 20852-1448

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