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Review of Amendment 52 Memo, Flublok


Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality
To:                  File STN 125285/0/52
From:             Deborah Trout, Committee Member, OCBQ/DMPQ, HFM-675
Through:        Carolyn Renshaw, Branch Chief, OCBQ/DMPQ, HFM-675
Subject:          Review of amendment 52 containing responses to Information Request Letter received December 7, 2011 submitted February 17, 2012 by Protein Sciences Corporation (hereafter referred to as PSC).
Action Due Date: January 16, 2013
Review and Comments
CBER Comment 1a.
b. You have provided data in various submissions to support column re-use for H1, H3 and B rHA----b(4)-------- process steps.
It is unclear if you can achieve acceptable separation at flow rates of ---b(4)---------------------------for the –b(4)-------- columns, respectively. Please comment.
To determine whether you have established adequate –b(4)- acceptance criteria please
provide baseline –b(4)- levels from the –b(4)----------- columns prior to their use in production.
PSC Response:
Acceptable column running conditions for all rHA subtypes and resins are supported by the following information:
  • A tabular listing of the number of –b(4)------ column resin uses, uses per pack, and the column acceptance criteria for all subtypes was provided in Tables 1-1 and 1-2.
1 page determined to be not releasable: b(4)
 --b(4)------------------------------------------------------ ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[        b(4)                                                                     ]
--b(4)--- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[            b(4)                  ]
[           b(4)                                                                           ]
[          b(4)                                                                                  ]
The firm’s response flow rate, column reuse and –b(4)- levelsappears acceptable. I defer the review of void volume acceptance criterion to the product reviewer.