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Vaccines

Record of Telephone Conversation - April 30, 2009- Prevnar 13

System Info - 101573  SHONE, DEANNA   06-Aug-2009 15:55:34  SHONEDE

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:  30-APR-2009 04:35 PM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  MICHAEL SMITH

Telecon Summary:
Email: IR request from DPQ for SOPs and contact info

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
From: Smith, Michael (CBER)
To: "DEVLINC@wyeth.com";
cc: Vaillancourt, Julienne;
Subject: RE: Request for documents for reviewing BLA
Date: Thursday, April 30, 2009 4:35:56 PM
Attachments: BLA 125324 requested documents 30APR09.pdf

Carmel,

Please provide the items listed in the attached document, as requested by Dr. Rajesh Gupta, Deputy Director, Division of Product Quality (DPQ) in the Office of Vaccines Research and Review OVRR). Per Dr. Gupta, these items are necessary in preparing for product testing in support of the BLA. In addition, please provide contact information for the appropriate individual at Wyeth who would work with Dr. Gupta and others at DPQ in providing reagents and technical support in transferring methods required for testing.

Thank you,
Mike
301-827-9047

List of Documents Required from Sponsor to complete Review of Biologic License Application (BLA) of Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), STN 125324

A.        Please provide detailed procedures (SOPs) for the following methods performed on Drug Substance.

  1.                   ------------------------------(b)(4)-------------------
  2.                   ------------------------------(b)(4)-------------------
  3.                   ------------------------------(b)(4)-------------------
  4.                   ------------------------------(b)(4)-------------------
  5.                   ------------------------------(b)(4)-------------------
  6.                   ------------------------------(b)(4)-------------------
  7.                   ------------------------------(b)(4)-------------------
  8.                   ------------------------------(b)(4)-------------------
  9.                   ------------------------------(b)(4)-------------------
  10.                   ------------------------------(b)(4)-------------------
  11.                   Sterility Test

B.        Please provide detailed procedures (SOPs) for the following methods performed on Drug Product.

 

  1.                   Aluminum  ------------(b)(4)------
  2.                   ---------------------(b)(4)-------------
  3.                   Identity, CRM197 by -----(b)(4)----
  4.                   Identity, Polysaccharide by ----(b)(4)----
  5.                   Polysorbate 80 by -----(b)(4)----
  6.                   Protein - ----------(b)(4)------
  7.                   Protein - ----------(b)(4)----
  8.                   Sterility by -------------------(b)(4)----------------

C.        Please provide method validation protocols describing experimental design to evaluate relevant method validation characteristics and method validation reports for the following methods.  Method Validation Reports should show reportable results also in addition to data analysis for evaluation of method validation characteristics. For example, data for accuracy and precision should show reportable results in terms of µg/ml of individual polysaccharides, not only % -------------------(b)(4)----------------.

            Drug Substance (for All Conjugates)

 

  1.                   -------------------(b)(4)----------------
  2.                   -------------------(b)(4)----------------
  3.                   -------------------(b)(4)----------------
  4.                   -------------------(b)(4)----------------
  5.                   -------------------(b)(4)----------------
  6.                   -------------------(b)(4)----------------
  7.                   -------------------(b)(4)----------------
  8.                   -------------------(b)(4)----------------
  9.                   -------------------(b)(4)----------------

Drug Product

 

  1.                   Aluminum  by ---------------(b)(4)---------
  2.                   -----------------------(b)(4)-----------------------
  3.                   Identity, CRM197 by -----(b)(4)-------
  4.                   Identity, Polysaccharide by ------(b)(4)-----
  5.                   Polysorbate 80 by ------(b)(4)---
  6.                   Protein - -----------------------(b)(4)----------
  7.                   Protein - -----------------------(b)(4)---------

For compendial methods, such as sterility and endotoxin, please provide method verification reports.

 

D.                Please provide a detailed procedure for preparation and characterization of reference preparation used in the ----------(b)(4)----- test (----(b)(4)-----) of Drug Product.

 

E.                 Please provide a template of the Lot Release Protocol.

 

 

 

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