Telecon CMC, January 27, 2010 - Menveo

Submission ID:                      Office: OVRR
BLA 125300   Menveo                                    

Title:            Meningococcal (Neisseria meningitidis) Tetravalent Oligosccharide Serogroups A, C, Y, W-135 Conjugate (diphtheria toxin CRM197; Corynebacterium diphtheriae) Vaccine

Sponsor:      Novartis Vaccines and Diagnostics Inc

Telecon Date/Time:   27-JAN-2010 11:00 AM          

Telephone Number:    (617) 871-4280

Author:                         CARA FIORE                         

Purpose:      Information Request

FDA Participants:
CARA R FIORE
WILLIE VANN
ELIZABETH VALENTI

Sponsor Participants: 
CHRIS WEBSTER

Amendments:   None

References

Summary of Discussion: 
1) Date of manufacture of two components MenCWY and MenA (lyo) - how do you define date of manufacturing?
a - Liquid vial of MenCYW-135 is date of formulation, and the product --b(4)-----------------------------
b- Lyophilized MenA – is the date of formulation, and the product ---b(4)---------------------- lyophilized -----b(4)----------------------

2) What is the lot # for the vaccine as packaged and sold?
This was faxed to Joe Quander but Novartis  will email us the information.

3) The BLA file needs to be updated for specifications because the LRP is up to date but the BLA file is not up to date.
Novartis was waiting until the Lot Release Protocol was finalized, but can submit this to the BLA.