Information Request Email, January 22, 2013 - ALPROLIX

From: Thompson, Edward
Sent: Tuesday, January 22, 2013 4:07 PM
To: 'Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)'
Cc: Kirschbaum, Nancy; Huang, Ellen (CBER); Debra Segal
Subject: Information Request for BL 125444/0

Contacts: Nadine D. Cohen PhD

Dear Dr. Cohen:

We are reviewing your December 28, 2012 biologics license application (BLA) for Coagulation Factor IX (Recombinant), Fc Fusion Protein. We determined that the following information is necessary to continue our review:
1.Please provide the following information to support your established procedures for prevention of contamination and cross-contamination:
a.A description and summary of the validation for sterilization of equipment and components used for manufacturing the drug substance, drug product, and diluent. The information provided should also include a summary supporting validation for the ---(b)(4)--- sterilization of the diluent.
b.A summary of your cleaning validations for manufacturing equipment, including your chromatography systems and columns;information provided shouldinclude your acceptance criteria
c.A summary of your facility cleaning validations; information provided should include your facility organisms and your disinfectant effectiveness studies
d.Please clarify how you segregateproduct/processes that are performed pre-virus clearance from those performed post-virusclearance. Please also indicate how pre- and post-viral areas are separated with respect to placement of air handling units (AHU). Please provide a drawing with the floor plan that includes the AHUs.
e.A description and a summaryof media fill simulations for your drug product
f.A summary of the environmental monitoring program for your drug product, including acceptance limits and frequency of sampling for viable and non-viable particles

The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.

Please submit your response to this information request as an amendment to this file by February 5, 2013 referencing the date of this request. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.

The action due date for this file is December 28, 2013.

If you have any questions, please contact me at (301) 827-9167.

Sincerely,

Edward Thompson
 Regulatory Project Manager
 FDA/CBER/OBRR/DBA/RPMB

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