DATE: February 20, 2009
TIME: 3:30 PM
PRODUCT: Japanese Encephalitis Virus Vaccine
TO: The BLA File - 125280
FROM: Robin Levis, DVP
PARTICIPANTS: CBER: Robin Levis, Li Yu, and Lewis Markoff, DVP
Intercell: Paul Wilson
SUBJECT : Discussion on Lot Release Protocol and Lots Submitted for Review
We contacted the sponsor to relay information regarding the two lots of material submitted for review in the BLA, lot numbers -----------(b)(4)---------------. Both of these lots failed the specification for protamine sulphate and one lot, ---(b)(4)----, failed the potency specification. The following points were discussed with the sponsor:
- It was determined by the review committee that these lots are not acceptable for release to market. This decision was based on the failed test results and due to the fact that the manufacturing process used to produce these lots is different from the final process that will be approved in the license.
- The sponsor was told that it is not critical to have lots submitted to CBER at the time of approval; however it was important for us to be able to review lots made using the approved manufacturing procedure. The sponsor was asked to submit a list of all final container lots and to submit lot release protocols for these lots when available.
- The current lot release protocol incorrectly specifies a --(b)(4)-- dating period. The sponsor currently has data to support an only 18 month shelf life. The sponsor will need to update the lot release protocol to reflect this difference.
- The current lot release protocol includes a specification for protein analysis by --(b)(4)- ---------------------------------------------------------------------- analysis. There is no data included in the lot release protocol, only the statement “yes” to indicate that the appropriate -(b)(4)- is seen. The sponsor was asked to include pictures of the -(b)(4)- showing the viral specific protein --(b)(4)-- .
- The sponsor then stated that the EU approval of this product was expected on February 26, 2009 and we were asked if we had any indication when the CBER review would be completed. We answered that US approval would follow the resolution of all outstanding issues.
- The sponsor then relayed information from a telecon with OCBQ related to the compliance status of the contract filler, -----(b)(4)----- will finalize responses to the 483 that was issued in ------(b)(4)------ and then meet with the compliance team at CDER, who were responsible for the inspection. This meeting will occur in the first week of March. Following resolution of compliance issues with CDER, this file will be clear for a CBER compliance check. We responded that we would follow up as necessary.
The call ended at 3:57 PM