
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.