Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

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.
-
-