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Immunogenicity Assay Development Memo - GLASSIA, March 22, 2010

Food and Drug Administration
Center for Biologics Evaluation and Research
Memorandum

Date:   3/22/10 

From:  Jennifer L. Reed, Ph.D.; CBER/OBRR/DH/LPD
HFM-345; 301-496-0625

To: File 125325

Through: Dorothy Scott, M.D.; CBER/OBRR/DH/LPD; HFM-345; 301-827-3016

Cc:  Cherie Ward-Peralta; OBRR/DBA/RPMB; HFM-380; 301-827-9170

Subject: Immunogenicity Assay Development

Product: Alpha-1 Proteinase Inhibitor (Human) intravenous for chronic augmentation and maintenance therapy in individuals A1PI deficiency and emphysema
Submission Date:  December 28, 2009
Manufacturer: Kamada, Ltd.

Recommendation:

The following letter-ready comments may be faxed to the Sponsor:

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.