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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Teleconference Memorandum - Weekly Update Telecon, March 16, 2007

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:

  1. Erata document
  2. The information on Aseptic Process Validation for Module (b)(4) should be included in BLA. Please submit an amendment.
  3. 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:
    1. procedures and processes to ensure product segregation and prevention of cross contamination upon receipt of starting material through distribution of final product
    2. line clearance and cleaning procedures for the clean room Modules used
    3. 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?