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
- 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?