Record of Telephone Conversation - December 16, 2009 - Prevnar 13

System Info - 119989  SMITH, MICHAEL J  16-Feb-2010 11:28:49  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:                                                                       
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  16-DEC-2009 12:55 PM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Other

Author:  MICHAEL SMITH

Telecon Summary:
Issues agreed upon with sponsor during December 1, 2009, telecon

FDA Participants:   Rajesh Gupta, Karen Campbell, Julie Vaillancourt and Mike Smith

Non-FDA Participants:    Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

E-mail:

______________________________________________

From:                     Smith, Michael (CBER) 
Sent:                      Wednesday, December 16, 2009 12:55 PM
To:                          'Love Jack'; 'Devlin Carmel'
Cc:                          Vaillancourt, Julienne; Gupta, Rajesh; Campbell, Karen M
Subject:                RE: RE: Information request #2, 16DEC09

Jack and Carmel,

   I apologize, the list of items below were agreed upon during the telecon on December 1, 2009, there is no action needed at this time.

Mike

_____________________________________________

From:                     Smith, Michael (CBER) 
Sent:                      Wednesday, December 16, 2009 12:35 PM
To:                          'Love Jack'; Devlin Carmel
Cc:                          Vaillancourt, Julienne; Gupta, Rajesh; Campbell, Karen M
Subject:                RE: Information request #2, 16DEC09

Jack and Carmel,

   Dr. Rajesh Gupta requested clarification on the following items related to the telecon that occurred on December 1, 2009.  Please submit your responses to the BLA as an amendment.

Issues that were addressed in the telecon on December 1, 2009

1          Free Saccharide Assay Using --------------(b)(4)----------------

In Table 6-1 (Responses to June 19, 2009 Question 6, submitted in Amendment 0.22 received on July 22, 2009) in the columns under % Free Saccharide and % --------------(b)(4)--------, please clarify the definition of "N".  It is not clear whether this represents the number of replicates or the number of different lots investigated. 

N = the number of assays performed.

2          Molecular Size Determination (--------------(b)(4)----------------------------------------------------------------

System suitability test is described in V-C-1098-06, but not in the SOP. As described in ---(b)(4)----, the system suitability is an integral part of any ---------------------(b)(4)------ assay. Please create a section in the SOP requiring a check for system suitability.

Wyeth does not perform the system suitability as part of every test. However, a monthly calibration for ---(b)(4)----performance with acceptance criteria is performed. The monthly calibration of ----(b)(4)---- will be included in the SOP. 

3.         Specific Issues Regarding Validation of Test for -----(b)(4)-----

Please provide the actual quantitative results for -(b)(4)-- rather than an indication that the test result falls below specification, particularly when the results are above limit of quantitation of the method.  This assay is not presented as a limit test. 

Wyeth explained that some reported results are less than a value higher than the limit of quantitation has to do with a calculation performed to convert ------------------------------------------------------------------------(b)(4)--------,.  In such a case the limit of quantitation depends upon the -------------------(b)(4)-------------------------------------------------------. CBER is satisfied with the explanation.

4.         Sterility Test

For the sterility test, you provided both options of ---------------(b)(4)--------------------------------------. Please specify one method that has been qualified for bacteriostasis and fungistasis with the product matrix. 

 

Wyeth explained that they were performing ----------------------(b)(4)---------------------------------------------.  Wyeth has switched to the --------(b)(4)------ at all sites performing this test. ---------(b)(4)------- was qualified for bacteriostasis and fungistasis with the product matrix.

Let me know if you have any questions.

Thanks,

Mike

Mike Smith, Ph.D.
Lieutenant Commander (LCDR), U.S. Public Health Service
Regulatory Project Manager
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

Phone:    301-827-9047
BB:         240-839-0823
Fax:        301-827-3532
E-mail:   michael.smith2@fda.hhs.gov

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