
Record of Telephone Conversation, February 20, 2013 - Q-Pan

 
 

Submission Type: BLA 

Submission ID: 125419/0

Office: OVRR

Product:
 Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant:
 ID Biomedical Corporation of Quebec

Telecon Date/Time: 20-Feb-2013 10:24 AM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
 1. Advice

Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:
 Comments regarding leachables studies

FDA Participants: Carmen Collazo-Custodio, Jeremy Wally, Kirk Prutzman

Non-FDA Participants: Michael Schwartz, Jillian Horvath

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


From: Collazo, Carmen 
Sent: Wednesday, February 20, 2013 10:24 AM
To: Michael Schwartz; Jillian Horvath
Cc: Collazo, Carmen; Wally, Jeremy; Prutzman, Kirk C
Subject: STN 125419 - recommendation on leachables studies 
Importance: High

Dear Dr. Schwartz,

We have the following comments regarding leachables studies:
1.You propose to store the H5N1 –b(4)------------------------- for–b(4)----------------------------------------------------While you provided stability data for –b(4)--,thedata from extractablesstudies for these–b(4)---------------- are limited (up to a maximum of6 months).These data are insufficient to draw any conclusions about theleachables profileof these–b(4)---- for –b(4) storage for the proposed shelf life of –b(4)-----. 

We recommend that the leachables studies be carried out in presence of the –b(4) for the length of the proposed shelf life and that you provide these data to us as they become available. Such studies can be part of theongoing long term stability studies for the H5N1 –b(4) in the–b(4)------------------. As an additional control, we recommend that you also include newly filled –b(4)------------------- with H5N1 antigen –b(4) and/or monovalent seasonal influenza virus vaccine. 

2.The H5N1formulated drug product will be stored in final container glass vials for3 years.While the data provided support the stability of the H5N1formulated drug product up to 36 months, theE/Lstudies for the H5N1formulated drug product stored in theseglass vials have been performed up to a maximum of12 months. We noted that --b(4)------------------------------------------------------- were detectedin these studies. These data are insufficient to draw any conclusions about theleachables profileof thesefinal container glass vials for the proposed shelf lifeof 36 months.

We recommend that leachables studies be carried out inthese glass vials in the presence of the H5N1 drugproduct for the length of the proposed shelf life as part of theongoing long term stability studies for the H5N1final container lots.As controls, we recommend that you also include newly filled container vials with H5N1 antigen DP and/or monovalent seasonal influenza virus vaccine. 


Please consider submitting protocols for the above studies to BB-IND 13413 for our review and concurrence.

Regards,

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: carmen.collazo@fda.hhs.gov

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