Information Request Email, January 25, 2013 - ALPROLIX

From: Thompson, Edward
Sent: Friday, January 25, 2013 2:45 PM
To: 'Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)'
Cc: Kirschbaum, Nancy; 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 are providing the following comments and request for additional information to continue our review:

Regarding viral clearance capacity of your manufacturing process:

1. The intended commercial process does not incorporate a -------(b)(4)------- step. -(b)(4)----------------- is considered to be of critical importance for viral safety assurance of recombinant protein therapeutics derived from cells of human origin. Please provide a risk assessment for the viral safety of your intended commercial product based on the intended commercial manufacturing process.

2. The manufacturing process used in early clinical development (submitted to IND 13487) incorporated a ------------(b)(4)------------ step following -------------(b)(4)-------------. Please provide compelling evidence to justify the removal of this -----------(b)(4)----------------------------step. Alternatively, you may consider incorporating and validating for -----(b)(4)------------------------ step.

3. Please be advised that only one of the (b)(4) chromatography steps validated for viral clearance may be claimed in the product label since all (b)(4) following the same principle of capturing the desired product and washing away impurities, and therefore, are not orthogonal.

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 7, 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

THIS DOCUMENT IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL AND PROTECTED FROM DISCLOSURE UNDER APPLICABLE LAW. 
 If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying or other action based on the content of this communication is not authorized. If you have received this document in error, please notify us immediately by telephone and return it to us at the above address by mail. Thank you.
