Submission Type: BLA Submission ID: 125363/0 Office: OVRR Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 22-Jan-2010 08:30 AM Initiated by FDA? Yes
Telephone Number: -------(b)(4)--------
Communication Category: Information Request
Author: JASON HUMBERT
Telecon Summary: Discussion of availability of Hib-TT lots for testing
FDA Participants: Jason Humbert, Jennifer Bridgewater, Joseph Temenak, Karen
Campbell, Milan Blake, Willie Vann, Tina Roecklein
GSK Participants: Jody Gould, Norris Pyle, Pierre Voet, Kalliopi Grigoriadou
Telecon Body: GSK previously contacted CBER about a problem regarding the lack of availability of Hib-TT lots for testing in support of MenHibrix GSK discovered when preparing component lots for submission to CBER for testing that currently, GSK has no Hib-TT that is not expired. GSK further stated that production of additional Hib-TT lots was not scheduled until early May 2010. GSK acknowledged that this was a potential problem in terms of timing of approval of the BLA, since the action due date was in June and their current production planning would not give CBER adequate time for testing. GSK offered to send expired lots, if available, but CBER has stated that expired lots would not be acceptable for testing.
CBER requested this teleconference to clarify the availability of Hib-TT and to discuss the possibility of beginning production earlier than May. GSK was able to produce (b)(4) representative lot, ----(b)(4)-------, which was originally manufactured with the intent for use for Hiberix, but was then used for ex-US supply. Therefore, this lot is only representative of the US process, but is not a US lot. GSK offered to supply additional material from the ----(b)(4)------- lot, but CBER noted that (b)(4) lots would be needed for testing at CBER. While the Hib-TT component in MenHibrix is similar to the Hib-TT component in Hiberix, there is a critical difference in the TT component. The TT component for MenHibrix is manufactured in -------(b)(4)------- by GSK, while the TT component for Hiberix is manufactured by -------(b)(4)------- for GSK. GSK stated that they will be releasing MenHibrix off the final container and not the bulk product. CBERacknowledged this but noted that Hib-TT was a critical component that is part of the lot release protocol.
CBER asked GSK if it would possible to move up production. GSK Belgium personnel stated that they had previously asked their planning department this question but they would not give them specific time frames. CBER recommended that GSK consider discussing this issue further with their firm management so that the lack of Hib-TT would not hold up approval. CBER and GSK discussed the fact that sufficient time would be needed for manufacturing of the Hib-TT component and testing of the product at CBER. Ideally, testing should be completed about a month before the due date. (Note: testing at CBER takes 2 – 4 weeks). GSK stated that they would check internally to see how soon they could provide Hib-TT lots to CBER. GSK will attempt to escalate production, but will continue to look for (b)(4) representative lots, as well. GSK asked if it would be possible to submit the Hib-TT lots to CBER for testing prior to GSK release (concomitant testing). CBER agreed that concomitant testing would be possible, but reminded GSK that this would be at the manufacturer’s risk. GSK acknowledged this potential option. GSK stated that they had submitted samples from (b)(4) lots of all other components to CBER for testing. GSK asked whether CBER would be able to move ahead with the testing of all other components with the exception of Hib-TT, and CBER agreed that we would proceed with testing of all other component lots submitted.
CBER summarized the action items requested for GSK. Specifically, GSK would check to see if they have any other Hib-TT lots anywhere else (i.e. ex-US lots or lots in laboratories) for testing. GSK would explore further the potential of revision of their production schedule. Norris Pyle from GSK stated that GSK will provide this information as soon as possible to CBER, noting the potential implications to the review of the application if adequate product is not available for testing.
No further issues were discussed and the call concluded.