Information Request Email, October 10, 2013 - ALPROLIX

From: Thompson, Edward
Sent: Thursday, October 10, 2013 8:03 AM
To: 'Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)'
Cc: Debra Segal; Huang, Ellen (CBER) (Ellen.Huang@fda.hhs.gov); Kirschbaum, Nancy (Nancy.Kirschbaum@fda.hhs.gov)
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.In amendment STN 125444/0/22, you stated that equivalent equipment can be used if qualified and implemented via change control. If these changes are made, please ensure that they are appropriately reported to the agency.
2.Please clarify if the sterile filters used for the Bacterial Challenge Testing mimic the actual process that they are used for. Specifically, if the sterile filters you use for production are ------(b)(4) sterilized prior to use, did the filters used during validation also experience this sort of worst-case thermal stress during testing?
3.Per 21CFR610.14, “the contents of a final container of each filling of each lot shall be tested for identity after all labeling operations shall have been completed.” Please clarify if identity testing will be performed after labeling has been completed.
4.Regarding your shipping validations for the drug product and diluent, please compare the simulated testing conditions to the actual shipping conditions with regards to temperature, time, and conditions.

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 October 21, 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.

Please send an acknowledgement message for receipt of this request.

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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