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Vaccines, Blood & Biologics

Record of Email Communication, December 7, 2009 - MenHibrix

Submission Type: BLA       Submission ID: 125363/0      Office: OVRR Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

GlaxoSmithKline Biologicals

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.

Reagents Required:

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.

V/r, Jason


Jason Humbert
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

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