
Information Request Email, Facilities, July 18, 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: 18-Jul-2014 02:24 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR regarding Facilities

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: SUSANNE MARTZ, PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C 
 Sent: Friday, July 18, 2014 2:24 PM 
 To: 'susanne.martz@novartis.com'; Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Naik, Ramachandra; Wolfgang, Edward
 Subject: STN 125546 Information Request

Ms. Martz and Dr. Stoehr,

We have the following request for additional information regarding STN 125546 (Recombinant Meningococcal Group B Vaccine). As discussed with LCDR Ertel, please provide the following manufacturing facility information: 
1.In reference to the Novartis Rosia Facility (Building (b)(4)):
a.Are the rooms used for OMV production newly constructed? When were they qualified for use? Are these rooms similar in construction and design of other processing rooms (in Building (b)(4)) used for manufacture of US approved products?
b.Has the US FDA inspected the OMV production rooms in Building (b)(4)? 
c.Is the equipment used for OMV production similar (i.e. construction, design, and size) to the equipment used for other US approved product manufactured in Building (b)(4)? What OMV equipment is shared and qualified for use with other US approved products?
d.Are the utilities (i.e. water, steam, compressed air, HVAC) that supply the OMV production rooms qualified for use with other US approved products?
2.In reference to the -----(b)(4)----- Facility:
a.Are any of the other US approved products (produced in E. coli) manufactured in similar manner to the 4CMenB recombinant proteins? If so, please provide a process flow comparing the manufacturing steps and equipment. 
3. Provide a consolidated list of all testing facilities used for quality control testing of 4CMenB (all stages of manufacturing).

Please submit your responses as an Amendment to your BLA (STN 125546) by Friday July 25, 2014, or sooner. To expedite review, you may also submit the electronic documents directly to Kirk Prutzman (kirk.prutzman@fda.hhs.gov) and Donald Ertel (Donald.Ertel@fda.hhs.gov) via email prior to officially submitting them to the BLA. In the cover letter of your Amendment, please indicate any documents that were emailed to CBER prior to submission and state that the documents in the Amendment are the same as the documents that were emailed to CBER. 

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, 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
