DATE: February 24, 2009
TIME: 11:00 AM
PRODUCT: Japanese Encephalitis Virus Vaccine
TO: The BLA File - 125280
FROM: Robin Levis, DVP
This call was held to review data on final container lots available to support licensure of this product. The sponsor submitted data on all lots manufactured for the US market, including:
- Two lots previously submitted to CBER for review, ------------(b)(4)-------------, which were rejected for release based on failed test results.
- Four lots produced since the final manufacturing process has been validated.
All available in process and final release test data for all of these lots was also sent for review.
The sponsor described the information submitted and then discussed the status of the validation for the -(b)(4)- assay used for in process testing. We acknowledged the work being done on this assay as important, but not critical for license approval. The critical final container identity test, done by -(b)(4)- , has been validated and is being used to test all lots intended for the US market.
CBER requested that the sponsor submit samples for the new lots for concurrent release testing. They agreed to initiate the shipment of these lots. The sponsor agreed to keep CBER up to date with the on going testing and lot release for the new lots described.
In addition, the sponsor agreed to implement the changes requested during the telecon on February 20, 2009. These included recognizing that the shelf life of the product should be indicated as 18 months, -----(b)(4)-----, and attaching to each future LRP actual copies or originals of -----------------------(b)(4)------------------------, rather than the simple statement that the -(b)(4)- results were satisfactory. Sponsor was reminded to use an appropriate positive control on each -(b)(4)- , preferably consisting of results obtained by ---(b)(4)--- of a sample from one of their reference lot(s).
The call ended at 12:00 noon.
PARTICIPANTS: CBER: Robin Levis, Li Yu, and Lewis Markoff, DVP
Bill McCormick and Rajesh Gupta, DPQ
Eric Henchal, OVRR
Intercell: Paul Wilson, Thomas Lingelback, David Venables, Fraser Leslie
SUBJECT : Discussion on Lots to be submitted for release.