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Product Review Memo, August 29, 2011 - MenHibrix


Date:                August 29, 2011
To:                   File for 125363/0
From:               James E. Keller, Ph.D.
Through:           Drusilla Burns, Chief
Subject:            Product Review Memo of sponsor’s responses to CR questions pertaining to Tetanus Toxoid Manufacturing and Testing
Sponsor:           GlaxoSmithKline (GSK)
Menhibrix CR comment review
On 12 August 2009, GSK submitted a Biologics License Application (BLA) for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine. The proprietary name is MenHibrix. On 11 June 2010, CBER issued a complete response (CR) Letter to the firm. On 14 April 2011, the firm submitted responses to the questions in the CR Letter.
I completed my review of the firm’s responses to questions that I asked in the CR Letter taken from my original review memo from May 2010. The firm’s responses have resolved all but one item (See Question 57). The details of my review of these items are contained below.  
7 pages redacted due to (b)(4)
convert data between the two assays. This clarification adequately settles the concerns noted in Question 58.  
58 (c) The lots in question, Lots ---b(4)-------------------------, are commercial purified        --b(4)-------TT produced at commercial scale. These lots were used for the manufacture of Hiberix vaccine. I have no further concerns.
The following three comments were not included as CR items.
Comment 1: The firm needs to provide additional validation data supporting the currently proposed –b(4)----- period for purified, ----b(4)---------------------- TT. 
This issue was covered by CR Question 25. Therefore, I withdrew this question from the CR Letter draft since Drs. Schmitt and Freedberg had already covered this concern.
Comment 2: The firm should provide validation data for the TT ----b(4)----------------------------- since it is the most pertinent test to assess antigen quality.
The firm stated that the –b(4)----- test is for monitoring purposes, therefore they did not submit validation data. This is acceptable.
Comment 3: The firm should provide the full validation report for the detection of ---b(4)------------------- The firm should explain why samples must be ---b(4)-------------------------------------- content. The passing specification is –b(4)-------- however the consistency lots demonstrate-b(4)---------- content is calculated using the lower limit of the calibration curve shown in Figure 17 (pp 95, Section 3.2.S.2.4).
Since the –b(4)------ test is a compendial test the firm did not submit validation data. Furthermore, the amount of –b(4)-------- in the vaccine is nearly eliminated from the product by subsequent isolation of ---b(4)--------------------------------------------------------------------- Therefore, --b(4)----------- is substantially lower than the ---b(4)------ quantity that the firm targeted for safety levels. With the low-end –b(4)----------- content in the product the firm’s rationale was considered acceptable.