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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Fax Transmission Record - GLASSIA, April 20, 2010

FACSIMILE TRANSMISSION RECORD
Division of Blood Applications
1401 Rockville Pike, Suite 400N, HFM-380
Rockville, Maryland 20852-1448

FAX  (301) 827-2857
TEL  (301) 827-9170


FAX No. 703-548-7457

To:  -----------------------------(b)(4)---------------------------------------
From: Cherie Ward-Peralta, OBRR/CBER/FDA
Date:   April 20, 2010

This Fax is regarding your submission, STN 125325/0 that was submitted to the Agency on May 29, 2009 as a biologics license application for Alpha-1 Proteinase Inhibitor (Human).  In order to facilitate the review of the BLA, FDA requests the following additional information:

CMC

  1. To aid in the ongoing review of your BLA submission, CBER requests an update on your activities toward refining the immunogenicity assay for Kamada-API.  Please include assay development milestones and a working timeline.  CBER would like to stress that a sensitive immunogenicity assay remains a high priority for this program.
  2. ---------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  3. In your current manufacturing process, bulk drug substance can be stored ---------(b)(4)----------   ---- prior to being processed to drug product. Please confirm that you will validate the hold time for drug substance in your comparability protocol that evaluates drug substance manufactured from ------------------(b)(4)----------------------.
  4. Please confirm that you will establish upper and lower limits for mixing speed, mixing time, and  -(b)(4)- contact time during the ---------------(b)(4)-------------------- containing -(b)(4)--.

We would appreciate a response to this information request by May 4, 2010. 

Please contact me if you have any questions.

Sincerely,

Cherie Ward-Peralta
Regulatory Project Manager
DBA/OBRR/CBER/FDA
Tel: (301) 827-9170