DATE: February 24, 2009
TIME: 11:00 AM
PRODUCT: Japanese Encephalitis Virus Vaccine
TO: The BLA File - 125280
FROM: Robin Levis, DVP
PARTICIPANTS: CBER: Robin Levis, Li Yu, and Lewis Markoff, DVP
Bill McCormick and Rajesh Gupta, DPQ
Eric Henchal, OVRR
SUBJECT : Internal Discussion on Lots to be submitted for release.
In preparation for a scheduled call with Intercell, the sponsor submitted information on four final container product lots that have been manufactured with the final, to be approved, manufacturing process. For each of these lots, most of the quality control testing has been completed, including the testing for protamine sulphate. All lots are conforming for all tests conducted to date. However, complete final container test results for two lots will not be available until the end of March and for the other two lots until May.
We had an internal discussion to determine whether the BLA could be approved with the data on these four lots as currently available or whether we needed to wait until all data was available for review. The general consensus amongst the review team was that we should wait for all data for the first two lots, -----------(b)(4)--------------, which will be available by the end of March. However, there was an increased comfort level with approving the BLA at this time and receiving that data as soon as it is available.
- Erik agreed to check with Norman regarding the necessity for final data to be submitted.
- To support approval, Bill and Rajesh agreed to concurrently test samples submitted for these two lots.