
Information Request Email, Bioburden Testing, December 10, 2014 - BEXSERO

 

 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR 

Product:
 Meningococcal Group B Vaccine 

Applicant:
 Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 10-Dec-2014 05:11 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN 

Telecon Summary: 
 IR regarding bioburden testing

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 

From: Prutzman, Kirk C 
 Sent: Wednesday, December 10, 2014 5:11 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Information Request

Dr. Stoehr,

We have the following request for additional information regarding STN 125546 (Meningococcal Group B Vaccine) for the Analytical Procedure for Bioburden testing in section 3.2.S.4.2 Analytical Procedures and the templates for recombinant protein ---------(b)(4)--------:

In light of your response to our comment on the template for the bioburden testing on the Lot Release Protocol templates for the ----------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------, CBER has examined the procedure submitted in the original BLA. As reported in section 3.2.S.4.2 Novartis has (b)(4) methods for testing bioburden using -(b)(4)- for the (b)(4) method and -----------(b)(4)------------- for the Novartis method. The test is performed by -(b)(4)- for in-process controls and release of ------(b)(4)-----, and by Novartis, for stability testing of the --------(b)(4)-------- only.

In order to comply with -(b)(4)-, CBER recommends that Novartis perform the method using ---(b)(4)--- for the release samples and provide a new bioburden method validation report showing suitability of the -(b)(4)- method in the presence of product as performed with ------------------------------(b)(4)-------------------------------------- on -----------(b)(4)---------- days as in accordance with -(b)(4)-----.

CBER received Novartis’s response (125546/0/27): bioburden test on ----------------------------------(b)(4)--------- is performed with the use of --(b)(4)--. The ------(b)(4)------- are released form -------(b)(4)------- as low bioburden products before shipping to Novartis, Rosia, IT for further processing. ---(b)(4)--- is considered adequate for the intended scope.

CBER does not agree with this assessment and asks that the -------(b)(4)---------- samples being tested for release use the method used for the stability samples and that the use of (b)(4) media be reflected in the lot release protocol template for bioburden.

If you have any questions about this communication, please contact Kirk Prutzman, Ramachandra Naik, or Ed Wolfgang at (301) 796-2640.

Regards,

Kirk Prutzman, PhD 
 Primary Reviewer/Regulatory Project Manager 
 CBER/OVRR/DVRPA/CMC3 
 Food and Drug Administration 
 10903 New Hampshire Avenue 
 Building 71 and Room 3041 
 Silver Spring, MD 20993-0002 
 Phone: (301) 796-2640 
 Fax: (301) 595-1244
