Information Request - VARIZIG, October 2, 2012

From: Cagungun, Nannette
Sent: Tuesday, October 02, 2012 4:51 PM
To: Terry Kraynyk
Subject: Information Request- VariZIG
Our Reference: STN 125430/0

Cangene Corporation
Attention: Mr. Terry Kraynyk
October 2, 2012

Dear Mr. Kraynyk:

We are reviewing your biologics license application for Varicella Zoster Immune Globulin (Human) submitted on June 29, 2012 for post-exposure prophylaxis of varicella in high-risk individuals. We have the following request for information:

 

1. Please provide the numbers and ratio of ----b(4)------------------------------------ plasma donors used in VariZIG manufacture, and how much these proportions can vary among VariZIG lots.

 

2. Please describe the algorithm and/or procedure by which you select VZV-hyperimmune donations to make up a manufacturing plasma pool.

3. How are VZV-hyperimmune donors selected for plasmapheresis? How are titers boosted in the vaccinated donors?

4. Please provide validation data for the –b(4)------------------------ when it is used to determine potency –b(4)----------------- final-product VariZIG.

Please submit your response to this information request as an amendment to this file by October 10, 2012 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.


If you have any questions, please contact me at (301) 827-6174.


Sincerely, 
Nannette Cagungun, MS, PD, RAC 
Regulatory Project Manager 
OBRR/CBER/FDA, HFM-380 
1401 Rockville Pike Rockville, MD 20852-1448 
Tel: (301) 827 6174 
Fax: (301) 827 2857 
Email: nannette.cagungun@fda.hhs.gov


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