
Record of Telephone Conversation, November 26, 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: 26-Nov-2014 10:00 AM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Advice

Author: RAMACHANDRA NAIK

Telecon Summary: 
 Clarification sought from Novartis regarding process validation for Aluminum hydroxide, unspecified impurities in ---(b)(4)---- and facilities.

FDA Participants: 
 Edward Wolfgang
 Kirk Prutzman
 Ramachandra Naik
 LCDR Donald Ertel
 John Cipollo
 Willie Vann

Novartis Participants: 
 Jim Wassil, Global Product Lead
 Joe Crowell, Project Management
 Davide Serruto, Technical Development
 Claudia Magagnoli, Technical Development
 Leonardo Gheradini, Quality
 Janne Uldal, Regulatory CMC
 Mark Fosbenner, Regulatory CMC
 Patricia Stoehr, Regulatory Affairs

Telecon Body: 
 CBER requested a teleconference to clarify issues regarding process validation for Aluminum hydroxide, unspecified impurities in -----(b)(4)--------------------, list of product-contact equipment/containers at -(b)(4)- facility and process validation for rp287-953 and rp936-741.

CBER asked if Aluminum hydroxide manufactured at --(b)(4)-- is used in other vaccines. Novartis responded that it was used in another vaccine but is not used or registered in the US. CBER indicated that no Aluminum hydroxide process description, validation data, and stability data was provided in the BLA and asked Novartis to submit the data. Novartis acknowledged and agreed to submit the information.

CBER asked how Novartis defines “unspecified impurities” in ---------------------------------(b)(4)--- test and how the test accounts for all the peaks -----------(b)(4)------------. CBER added that the justification provided under Section 3.2.S.4.5 of the BLA is incorrect due to the change in definition of unspecified impurities provided in response to Question 8 of the IR sent on October 8, 2014 (Amendment 0.23). The change in definition revealed that --------(b)(4)--------- would not be reportable in the ---(b)(4)--- Purity test data. CBER requested that -------(b)(4)------- and the main 287-953 peak, as well as unspecified impurities, be reported separately in the --(b)(4)-- data. Novartis agreed to make the requested change to the test. CBER also requested Novartis to provide a report for the summary of the validation campaign to ---------------------(b)(4)------------------ of the target proteins. Novartis agreed to submit the report.

Regarding facilities, CBER asked Novartis to clarify the --(b)(4)--/Novartis relationship and the reason that Novartis cannot provide the responses to DMPQ’s last IR directly to CBER instead of cross-referencing a DMF (as stated in per BLA 125546/0 amendment 26). Novartis replied that they interact with -(b)(4)- as a third party contractor, so -(b)(4)- does not share other company’s product information directly with Novartis. CBER then asked Novartis if they could provide a list, in table format, of products produced and the specific equipment used for each product, as well as confirm that cleaning procedures are established. Novartis proposed that they ask --(b)(4)-- to send the requested information directly to CBER. CBER responded that that proposal is acceptable and asked Novartis to have -(b)(4)- send the data to CBER within 5-7 days for expedited review. Novartis agreed. 

Call ended.
