
 


Teleconference Memorandum: Product Questions, March 15, 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 15, 2007

CBER Representatives: Malcolm Moos, Rafat Husain, Keith Wonnacott


    Sponsor’s Representative:
      Stephen Apone, Sr. Scientist I
      (b)(4), Associate Director, Contract Manufacturing (b)(4)
      Championsmith, Director of Regulatory Affairs Michael Covington,
      Sr. Director, Quality Assurance
      Karen Krstulich, Sr. Regulatory Affairs Manager
      (b)(4), Sr. Contract Manufacturing Manager
      Georgeta Puscalau, Director, Quality Control
      Terrence Rindler, Validation Engineer II
      Andrew Scherer, Vice President of Manufacturing
      Timothy Wood, Scientist I

STN : 125197/0

Subject: Product Questions

Discussion:

The sponsor was contacted to discuss the following review issues:
  Validation of the (b)(4) method for sterility testing.
  (b)(4) lifetime validation; small scale vs. manufacturing scale data
  Process intermediate hold times; small scale vs. manufacturing scale data
  Upper and lower limits for certain process controls
  Acceptance criteria for (b)(4).

With respect to issue 1, there was confusion on the part of the sponsor, in that 
the BLA referred to use of this test, but teleconference participants did not 
seem to be aware of this. FDA asked for clarification on this point, and also 
observed that the compendial tests for sterility would be perfectly acceptable.

The sponsor agreed to provide clarification regarding details of the 
validations, and to propose limits that were within, rather than at the edge of 
existing data from the validation studies (items 2 and 3).

The sponsor agreed to propose limits for the steps affected.

The sponsor agreed to consider our discussion of the possibility that (b)(4) 
might lead to some (b)(4) and to provide a response (note: the in-process and 
release testing methods in the BLA would identify such problems with high 
sensitivity and fail lots where became problematic, so this suggestion is 
considered advisory, rather than a regulatory requirement.)

The sponsor indicated that a response would be provided and discussed as needed. 
This was done on March 26, 2007, and the points discussed were addressed 
adequately, with the exception of an upper limit for protein concentration. All 
of these considerations have been addressed in the review, and letter comments 
provided where appropriate.

OCTGT:IOD:M. Moos:3/15/07
(N:/IOD/Tull/125197/tcons/031507_product.doc)
 
