Product Approval Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Division of Manufacturing and Product Quality

Date:	09/21/07
To:	Administrative File, STN 125254.0 Rakesh Pandey
From:	Carolyn Renshaw, CMC reviewer, CBER/OCBQ/DMPQ/BI, HFM-675
Through:	John A. Eltermann, Jr., R.Ph., M.S., Director, DMPQ/OCBQ/CBER, HFM-670
Subject:	BLA Review Memo: Mycoplasma Testing:
STN:	125254, Afluria, inactivated flu vaccine produced in ovo
Applicant	CSL
Due date:	09/28/07 (?)

Recommendation: The mycoplasma testing performed ---------------------------- appears adequate. There are no issues regarding mycoplasma testing to prevent approval of the BLA.

Review Summary
On 08/07/07 I was asked to consult on the mycoplasma testing for the subject BLA. On 9/14/07 I initiated my review of the submission. On 9/21/07, I consulted with Ms. Clara Lin of OCBQ/DMPQ/PRB and Dr. Vladimir Chizhikov, OVRR/DVP/LMD regarding mycoplasma testing on -----------------------------------------------------. Consultation resulted in the conclusion that viral harvest (allantoic fluid prior to inactivation) is not required to be tested for mycoplasma (regulation and points to consider require mycoplasma testing for viral harvests made from in vitro cell cultures) for inactivated vaccines produced in eggs. Although mycoplasma can be cultured in allantoic fluid, the viral inactivation step would also inactivate mycoplasma. However, we agreed it is prudent to test the working viral seed (and also the master seed virus) for mycoplasma. CSL is performing mycoplasma testing ---------------------.

Review Narrative
Section 3.2.S.2 Manufacture/Control of Materials
Section 3.2.S.2.3.1 Master Virus Seedlot (MVS) and Working Virus Seedlot (WVS)

Specific pathogens for which the flocks are regularly monitored include Mycoplasma gallisepticum and Mycoplasma synoviae.

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DETERMINED

TO BE

NOT RELEASABLE

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Review Comment
The - conformance lots met acceptance criteria for mycoplasma testing. No issues were identified.