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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Fax Transmission - GLASSIA, March 3, 2010

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: Nannette Cagungun, OBRR/CBER/FDA
Date:   March 3, 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. For the lots submitted to support manufacturing changes (------(b)(4)--------), for process parameters and in-process product quality attributes, please provide individual data and compare these data to historical results.
  2. Please supply vent filter in the product package.
  3. ----------------------------(b)(4)--------------------------------

a. -----------------------------------------------------------------------------------------------------------------------------------------------------

b. --------------------------------------------------------------------------------------------------------

  1. Please clarify whether ------------(b)(4)--------------- from both source and recovered plasma will contain --(b)(4)-- going forward. 

If ---------(b)(4)-------- from both source and recovered plasma will contain -(b)(4)- going forward, please state in your Comparability Protocol that -(b)(4)- full-scale batches of Kamada-API from source -(b)(4)- containing -(b)(4)-, and -(b)(4)- full scale batches from recovered        -(b)(4)- containing -(b)(4)-, will be manufactured.

  1. Please clarify whether qualification studies of -------------------(b)(4)------------ have been performed.  In the Comparability Protocol, you should manufacture a final container lot from -----------(b)(4)------------ which has been aged for the maximal amount of time you wish to claim, and enter the lot into your routine stability monitoring program.
  2. Please provide validation data that you have collected in research scale and pilot scale for -(b)(4)- contact time, mix time, and mixing speed for --------(b)(4)-------- containing -(b)(4)-.  The data set should include analysis of -(b)(4)-.  Please include validation of      -(b)(4)- contact time, mix time, and mixing speed in your Comparability Protocol.
  3. In your Comparability Protocol, please modify your acceptance criterion for quality attributes for in-process intermediates and DS manufactured from -------(b)(4)------            ----------. Quality attributes should be comparable to quality attributes observed historically. The comparison should not be limited to lots submitted to support the BLA.  You should show that quality attributes for all in-process intermediates are comparable with historic results, and not limit your analysis to in-process intermediates downstream of CM.

We would appreciate a response to this information request by March 17, 2010. 

Please contact Ms. Cherie Ward-Peralta if you have any questions.

Sincerely,

Nannette Cagungun, MS, PD, RAC
Regulatory Project Manager
DBA/OBRR/CBER/FDA
Tel: (301) 827-9170