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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Fax Transmission Record - GLASSIA, February 2, 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:   February 2, 2010

This Fax conveys our comments to your biological license application submitted on May 29, 2009 for STN 125325/0 for Alpha-1 Proteinase Inhibitor (Human). 

Immunogenicity Assay Development:

  1. Use of a ----------------------------------------(b)(4)--------------------------------------------------, is a good choice as a positive control.  However your calculation of sensitivity for the positive control assumes all of the antibody in the positive control is directed against A1PI.  --------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------------------------------------------------------
  2. -------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  3. In this assay it appears that ----------------------------------(b)(4)--------------------------------- to provide the basis of an improvised standard curve.  What is the efficiency of immobilization of your ---(b)(4)-- standard curve?  If unknown, the assignment of antibody concentration based on the standard curve is not valid, and the assignment of sensitivity values based on the standard curve is also invalid.

Please contact me if you have any questions.

Sincerely,

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