
Information Request Email, Residual Kanamycin, DS/DP Testing Facilities, January 21, 2015 - 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: 21-Jan-2015 02:15 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR regarding residual Kanamycin and DS/DP testing facilities

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, January 21, 2015 2:15 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: RE: STN 125546 - Information Request

Dr. Stoehr,

Please find attached an annotated table indicating the discrepancies in the email below. The rows with the discrepancies are highlighted in yellow. 

Kirk

From: Prutzman, Kirk C 
 Sent: Wednesday, January 21, 2015 1:57 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Information Request

Dr. Stoehr,

Here are the concerns regarding the residual Kanamycin calculation and the DS/DP Testing Site discrepancies discussed in our tcon earlier today. I will send you table indicating the testing site discrepancies shortly. We are available to discuss these issues further at any time this afternoon. Please submit the responses to these information requests as an Amendment to STN 125546 as soon as possible. 

Concerning the Kanamycin Calculation:

Please provide the basis of the (b)(4) in the following assumption:

--------------------------------------------------(b)(4)-------------------------------------------------------------------- is likely since the membranes have a molecular cut off of -(b)(4)- for -------------------(b)(4)------------------------------------ (vs molecular weight of --(b)(4)-- for kanamycin (b)(4)). However, a retention of -----(b)(4)-------------- in the ----(b)(4)------------ was assumed as a worst case.

Concerning the DS/DP Site Testing Table:

1. We note the following discrepancies. Please comment.
 a. For all three recombinant proteins, the table states that testing for release is done at (b)(4). The BLA method/validation state (b)(4).
 b. For the ---(b)(4), the table states that the testing for identity and endotoxin/protein for release and stability are done at (b)(4). The BLA method/validation state Rosia.
 c. For the ---(b)(4)------- for final product, the table states that testing for ---(b)(4)--------- for release and stability is performed at Rosia. It is unclear in the BLA where the validation was performed.

2. Testing performed at each site must be validated/qualified. Please add the following information to the table.
 a. The validation/qualification report number
 b. The site that the validation/qualification was performed. 

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 

5 pages determined to be not releasable: (b)(4)
