

Teleconference Memorandum - Weekly Update Telecon, March 16, 2007 - Provenge



 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 


 TELECONFERENCE MEMORANDUM                                                       
                                             Public Health Service
                                                                                 
                                                                Food and Drug 
Administration
                                                                                 
                                                                Center for 
Biologics Evaluation and Research

 

Date\Time: March 16, 2007

CBER Representatives: Keith Wonnacott, Stephanie Simek, Celia Witten, Boguang 
Zhen, Peter Bross, Kimberly Benton, Mark Davidson, Tom Finn, Ashok Batra, Lori 
Tull, Gang Wang

Sponsor’s Representative: Elizabeth Smith, Mark Frohlich, Lianng Yuh, Connie 
Spooner, Nicole Provost, David Urdal

STN : 125197/0

Subject: Weekly update telecon

Discussion:
  Erata document
  The information on Aseptic Process Validation for Module (b)(4) should be 
  included in BLA. Please submit an amendment.
  In Item 4, Section 3.2.A.1 Facilities and Equipment, Section 5.0 Other 
  Products, you state that you plan to manufacture sipuleucel-T and related 
  products for clinical use. The related products would be prepared (b)(4) with 
  sipuleucel-T. Please provide the following information: procedures and 
    processes to ensure product segregation and prevention of cross 
    contamination upon receipt of starting material through distribution of 
    final product
    line clearance and cleaning procedures for the clean room Modules used
    procedures and processes to ensure personnel segregation and prevention of 
    cross contamination, i.e., are operators and verifiers product- specific or 
    will they work on more than during a work day?

