

Information Request Email, CMC Issues, November 6, 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: 06-Nov-2014 04:28 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
 IR regarding CMC issues

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: Thursday, November 06, 2014 4:28 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra 
 Subject: STN 125546 - Information Request

Dr. Stoehr,

Please find attached a request for additional information regarding STN 125546 (Meningococcal Group B Vaccine). Please provide your responses to this information request in an Amendment to STN 125546 by November 21, 2014. 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


CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
 OFFICE OF VACCINES RESEARCH AND REVIEW
 DIVISION OF VACCINES AND RELATED PRODUCTS APPLICATIONS

DATE: NOVEBMER 6, 2014     PAGES: 2

TO: NOVARTIS VACCINES AND DIAGNOSTICS, INC
 ATTENTION: PATRICIA STOEHR, PH.D.
 Senior Group Manager Regulatory Affairs
 Novartis Vaccines & Diagnostics

350 Massachusetts Avenue
 Cambridge, MA 02139 
 USA

FAX: (617) 871-4711 TEL: (617) 871-8060

FROM: KIRK PRUTZMAN, PH.D.
 Regulatory Project Manager
 FAX: (301) 595-1244 TEL: (301) 796-2640

SUBJECT: STN: BL 125546/0 – Request For Information

MESSAGE:

Dear Dr. Stoehr:

We have the following request for additional information regarding your submission of Biologics License Application STN 125546 (Meningococcal Group B Vaccine):

Regarding drug substance RP287-953
1.In Section 3.2.S.4.3 ----(b)(4)--- [rp287-953- -(b)(4)-] and Validation Report 63440-vr-1-ver4, no validation data are presented to support assay robustness. You state that the robustness parameter was evaluated during method development by Novartis and applied by -(b)(4)- to testing of in-process controls and release of concentrated bulk. Please submit these data.
2.In Section 3.2.S.4.3 -(b)(4)- [rp287-953 - -(b)(4)-], the range validated for the -(b)(4)--------------------------------------------------(b)(4)-----------------------------. However, the test is used to quantitate the amount of Unspecified Impurities with limit of (b)(4). The method is not validated in this range. Please provide data showing that the -(b)(4)- --------(b)(4)------------------ Test is valid in the range of detection of ----(b)(4)--------------------------. Alternatively, please commit to submit this data post approval.

Regarding drug substance RP936-741
3.In Section 3.2.S.4.3 --(b)(4)-- [rp936-741- -(b)(4)-] and Validation Report 63441-vr01-ver3, no validation data are presented to support assay robustness. You state that the robustness parameter was evaluated during method development by Novartis and applied by -(b)(4)- to testing of in-process controls and release of concentrated bulk. Please submit these data.

Please provide your responses to this information request in an Amendment to STN 125546 by November 21, 2014. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference. If you have any questions about this communication, please contact Kirk Prutzman, Ed Wolfgang, or Ramachandra Naik at (301) 796-2640.
 

 
