
Record of Telephone Conversation, March 22, 2012 - MenHibrix

 

 
Submission Type: BLA    Submission ID: 125363/0    Office: OVRR
 

Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
 

Applicant:
GlaxoSmithKline Biologicals
 

Telecon Date/Time: 22-Mar-2012 09:00 AM        Initiated by FDA? Yes
 

Telephone Number: ----b(4)-------
 

Communication Categorie(s):
1. Other - 
 

Author: KIRK PRUTZMAN
Telecon Summary:
LRP discussion and 3-20-2012 IR discussion
 

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, TINA ROECKLEIN, WILLIE VANN, KAREN CAMPBELL, RAJESH GUPTA, ALFRED DEL-GROSSO, CATHERINE POOLE, FREYJA LYNN, JENNIFER BRIDGEWATER
 

Non-FDA Participants: JODY GOULD, NORRIS PYLE, NANCY CAUWENBERGHS, BERT DE KLERCK, DAVID LE TALLEC, CATHERINE POTY, CATHERINE VIGANO-WOLFF
 

Trans-BLA Group: No
 

Related STNs: None
 

Related PMCs: None
 

Telecon Body:
CBER and GSK met to discuss LRP comments and CMC IR sent to GSK on 3-20-2012.  
 

Lot Release Protocol Discussion:

3-20-2012 LRP Item 9a:  GSK agreed to align the terminology between the LRP and the contents of the BLA.  Thus GSK proposed using “Specification is not less than –b(4)-  The wording “of the total surface as –b(4)------TT” should not be added to the LRP.

3-20-2012 LRP Item 9c:  The name of the test should be “---b(4)------------------------ Method”.  CBER agreed that the terminology should be consistent with information submitted in the application.

3-20-2012 LRP Item 13d:  GSK indicated that the tests outlined in 13d were for purified TT and not Purified and –b(4)-------------TT.  It was discussed that this was consistent with the testing for Purified and –b(4)--------- TT for the Hib drug substance used in the MenHibrix and Hiberix vaccines.

CBER needed to discuss this further internally and get back to GSK.

3-20-2012 LRP Item 14:  GSK indicated that the –b(4)--- content should be via “---b(4)----------------------------------------

CBER agreed.

3-20-2012 LRP Item 19d:  GSK discussed that the terminology should be consistent between the LRP and the BLA contents, thus it should read “polysaccharide C content by calculation” with a specification of ---b(4)--------.

CBER agreed.

General LRP Discussion:

GSK stated that they were looking at an end of April timeframe for submitting the updated LRP.  CBER stated that GSK should submit an updates LRP as soon as possible to assure that there would be enough time for testing and releasing launch lots upon approval.

Reagents: CBER outlined that the last GSK communication was that new reagents would not be sent to CBER until May. GSK indicated that he would accelerate the shipment of these reagents.

Launch Lots:  CBER inquired as to the status of the launch lots.  CBER stated that testing uses considerable resources and that GSK should confirm the lots received in December 2011 are still Launch Lots.  GSK stated that currently the above lots are considered launch lots, but that this was being discussed internally.  GSK will confirm/communicate the status of the planned launch lots to CBER as soon as possible.

3-20-2012 IR Discussion:

3-20-2012 IR item 1:   

GSK acknowledged and will address.


3-20-2012 IR item 2:   Regarding the stability specification for –b(4)---------------------, CBER indicated that GSK should choose either the –b(4)------ method or the Belgium method and re-validate as a PMC.  CBER indicated that GSK only had data to support a    --b(4)---- expiration dating for Purified TT manufactured at –b(4)----.  GSK accepted the    --b(4)---- expiration dating for the Purified TT.

3-20-2012 IR item 3: 

 GSK acknowledged and will address.
 

3-20-2012 IR item 4:   GSK indicated that a limited numbers of batches are currently available and that they were produced in a limited numbers of production campaigns. Consequently, GSK expressed concern that setting the specifications at the LLOQ may not be accurate and could lead to the rejection of acceptable lots. GSK also emphasized that in addition to the release specification for ---b(4)----- content, alert levels have been set as outlined in response to Item 16.  For PSC purified bulk and FC the alert level for     -b(4)------- content is set at the LLOQ.  GSK proposed to justify specifications above the LLOQ based on the –b(4)------ levels on PS bulks used to formulated vaccines registered outside US and will further reviewed internally the proposed specifications, taking into account CBER’s comments.
 

3-20-2012 IR item 5: 

 GSK acknowledged and will address.
