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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Review of Amendment 52 Memo, Flublok

 

Memorandum
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.