System Info - 120967 SMITH, MICHAEL J 23-Feb-2010 16:27:07 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 19-SEP-2009 01:04 PM Initiated by FDA? Yes
Author: MICHAEL SMITH
E-mail: Procedures regarding generating working cell banks
FDA Participants: Julie Vaillancourt and Mike Smith
Non-FDA Participants: Jack Love, Carmel Devlin and Elizabeth Edwards
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Love Jack [mailto:LOVEJ@wyeth.com]
Sent: Saturday, September 19, 2009 1:04 PM
To: Vaillancourt, Julienne; Smith, Michael (CBER)
Cc: Devlin Carmel; Edwards Elizabeth
Subject: Follow-up on telephone call from Tina Rocklein and Willie Vann
Julie and Mike,
On Thursday, Tina and Willie called me and requested some additional information. One purpose of this email is to let Tina know where the documents are that she could not find in the dossier. Wyeth has provided the procedures for each of the 13 serotypes and CRM197 under 3.2.S.2.3 Procedure for Working Cell Bank Generation. Additionally, the tests and specifications to be used for the new working cell banks are listed in 3.2.S.2.3 Cell Banking System, Generation and Testing. Copies of these documents for serotype 1 are attached, and there are similar ones for every other serotype and CRM197. In addition, I will be submitting an amendment to the BLA for approval to file the change to new Working Cell Banks via the Annual Report, as Tina requested. Will you please forward this email to Tina?
Additionally, I am putting together some information on the rationale for linking specifications for ---------------(b)(4)------------------ to clinical data. I have not yet had an opportunity to review the specs for -------(b)(4)----- but we will look into this as well. In addition, I will be forwarding to the BLA as Willie requested the tables showing the specifications that Wyeth has tightened recently. These will be submitted to Module 1 on the BLA. As you and I discussed about 2 weeks ago, Wyeth commits to releasing all commercial lots according to the tighter specifications and post-approval to filing the supporting documents for these specification changes. The reason for submitting the additional documents post-approval is that there are numerous documents that will have to be updated, such as Justification for Specifications, Post-approval Stability protocols, Batch Analyses, and the Module 2 Introduction and Module 2 summaries, and most of these have 13 versions. We had discussed at the meeting on September 1st that there were no additional CMC requirements pre-approval, so this seems like a reasonable compromise, please let me know that this approach is acceptable.
Jack D. Love, Ph.D.
Assistant Vice President
Vaccine Regulatory Affairs
Wyeth Pharmaceuticals, Inc.
One Blue Hill Plaza BH 21125
Pearl River, NY 10965