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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, August 15, 2012 am - Flucelvax

 

Date/Time of Call:                             August 15, 2012 @ 9 AM
 
CBER Representative:                    
Ellen Huang, CSO, CBER/OCBQ/DMPQ/MRBII
Anissa Cheung, CSO, CBER/OVRR/DVP
Pete Amin, Reviewer, CBER/OCBQ/DMPQ/MRBII
Brenda Baldwin, Microbiologist, CBER/OVRR/DVRPA/CMC3
Tim Fritz, CBER/OVRR/DVRPA, Microbiologist, CBER/OVRR/DVRPA/CMC2
Tim Nelle, Sr. Supervisory Regulatory, CBER/OVRR/DVRPA/CMC2
 
Organization Representative:         
Matthew Gollwitzer, Regulatory
Manish Vyas, Regulatory
John Barry, Regulatory
Umang Shah, Regulatory
Christoper McDonald, Holly Springs Site Head Tech Ops
Mark Roache, Holly Springs Head Quality Ops
Rainer Kroener, Validation
Manfred Brunen, Tech Transfer
Stefan Knapp, Quality Assurance
Michael Glodeck, Validation Engineer
Karsten Kattmann, Technical Operations
 
Organization:                                    Novartis Vaccines and Diagnostics
                                                           
Telephone:                                         ---------------------(b)(4)------------------------------------
 
Subject:                                              BLA STN 125408/0
 
STN:                                                   STN 125408/0
                       
 
We contacted Novartis to discuss the firm’s responses to various amendments. The following information request questions were relayed to the firm.
 
  1. For the ------(b)(4)------------, please provide the testing parameters and frequency of the continuous routine monitoring and lifetime studies.
  2. Please provide the cleaning revalidation report for the -------(b)(4)--------------- (report # 289146 and 289148, respectively).
  3. Please provide the routine monitoring limit for (b)(4) for the ----(b)(4)-------and any (b)(4) routine monitoring results you have thus far for the ----(b)(4)------. Please provide justification for the ---(b)(4)---- you select for routine monitoring (e.g. statistical analysis) for the ----(b)(4)-------.
  4. Per your response in Serial Number 16 to US-OPF-016-6, your (b)(4) results from the ---(b)(4)-- cleaning validation was 5.5, 4.9, and 7.8 (b)(4). You also mention in Serial Number 16 that you may select a routine monitoring limit close to (b)(4). This limit appears high. We recommend you set an alert limit closer to the actual (b)(4) results you are obtaining.
  5. The container closure integrity test (CCIT) for the monovalent bulk was performed in 2005 and on a (b)(4) container. You indicated that you started a new for the (b)(4) monovalent bulk container in January 2012. Please provide a summary interim report of the new CCIT study.
  6. Regarding samples that are shipped from Marburg to Holly Springs for the SRID test, please describe how you maintain the sample integrity during the sample shipping and storage. Please provide data to demonstrate that there is no significant difference in the potency of the monovalent bulk during shipping. We suggest that you compare the SRID results using the same sample tested at both the Marburg and Holly Springs locations.
  7. Please confirm your plans for the Holly Springs location.
  8. Please provide supporting documents for the use of ----(b)(4)--------- for the sanitization of the -------(b)(4)------------------. Please state the maximum number of cycles (with justifications) and the duration for each cycle of the ------(b)(4)----------- used for the sanitization without compromising the performance of the resins.
  9. Please verify that the -------(b)(4)------------- assay performed after each sanitization is the same as the (b)(4) run. Please provide documents to show that the (b)(4) run data was captured after each sanitization run.
  10. Please provide the validation report for the ---(b)(4)--- of BPL for the initial process 1.0. The Attachment 3.2.S.3.2.6-1 you provided in the original BLA submission was not correct.
  11. Please provide SOP 223008 for the determination of BPL concentration by -----------------------------(b)(4)--------------------------------------------, as well as its method validation report 405032.
 
 
Call Ended at 9:45 AM