Submission Type: BLA Submission ID: 125363/0 Office: OVRR Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 07-Dec-2009 09:00 AM Initiated by FDA? Yes
Telephone Number: Communication Categorie(s):
1. Other - Request for samples and reagents for in-support testing of BLA 125363
Author: JASON HUMBERT Telecon Summary:
Request for samples and reagents required for in-support testing of BLA 125363
FDA Participants: Jason Humbert
Non-FDA Participants: Jody Gould, Ph.D., GSK
Telecon Body: The following e-mail was provided to GSK:
Good morning Jody,
OVRR has identified samples and reagents required for in-support testing of BLA
125363, Hib-MenCY-TT. We request the following:
1. Drug Product (final container) – ----(b)(4)--- lots – (b)(4) containers each
2. Drug Substance (individual conjugates) – --(b)(4)--- lots of each conjugate – -(b)(4)- each.
All in-house generated reagents used in testing of ---(b)(4)----. These reagents should be sufficient to perform about –(b)(4)-- assays, to perform in support and lot release testing.
Examples of reagents: Specific antibodies used in (b)(4) (Identity and ---(b)(4)-----, product specific standards and internal controls used in other assays
Please let me know if I can provide additional information/clarification regarding this request.
Regulatory Project Manager
Division of Vaccines and Related Product Applications
Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration
Tel: (301) 827-6019
Fax: (301) 827-3532