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Vaccines, Blood & Biologics

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End of Products Cell Bank

From: Miller, Daryll L

Sent: Friday, February 13, 2009 11:39 AM

To: 'Paul Wilson'

Cc: Daemer, Richard J.

Subject: End of Production Cell Bank

Hi Paul,

In getting to the end of the review process our CMC reviewer is having a problem locating information that was noted in the original BLA as "pending".

In section 3.2.S.2.3, control of materials, on page 19, Table 3.2.S.2.3.1-9 deals with testing of the end-of-production cell bank. All the entries in the results columns are listed as "pending". The reviewer could not find an update of this testing in any of the subsequent amendments.

Has this ever been submitted? If so, please let us know where the information can be found. If not, please let us know when you can provide it. This should be provided as another amendment to the BLA.

I will not be available this afternoon but Dick will. Please let him know when we can expect this information.


Daryll and Dick

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