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Vaccines

Record of Telephone Conversation, May 2, 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: 02-May-2012 12:01 PM        Initiated by FDA? Yes
 

Telephone Number: jody.a.gould@gsk.com; norris.h.pyle@gsk.com
 

Communication Categorie(s):
1. Information Request

Author: KIRK PRUTZMAN
 

Telecon Summary:
LRP comments and IR comments for CR Letter Items 12 and 14.  For discussion at the 5/3/2012 tcon.
 

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN
 

Non-FDA Participants: JODY GOULD, NORRIS PYLE
 

Trans-BLA Group: No

Related STNs: None
 

Related PMCs: None
 

Telecon Body:
 

From: Prutzman, Kirk C
Sent:  Wednesday, May 02, 2012 12:02 PM
To:      'Jody Gould'; 'Norris Pyle'
Cc:      Temenak, Joseph; Staten, David
Subject: STN 125363 - IR Comments for Tomorrow

Attachments:          STN 125363 IR-Comments 5-2-2012.pdf


Hi Jody and Norris, Please find attached our IR comments to be discussed at our tcon tomorrow. 

Regards, Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville, MD  20857
Phone:  (301) 796-2640

Comments in the attached pdf file: IR Comments (Teleconference 3 May 2012)

We have the following comments concerning your response to Question 2 of the IR sent 20 March 2012 (stemmed from Question 12 of CR letter dated 21 September 2011).  We recognize that the analytical methods used to assess the      --b(4)------------------ of TT are different between the –b(4)------- manufacturing site and the Belgian site.  We also recognize that preliminary studies on b(4) lots show that the ---b(4)--using the -(b)(4)---- method yield an average of approximately –b(4)- lower than that obtained by using the Belgian method.

a. Please provide a detailed scientific explanation for the –b(4)- difference in results between the two sites.

b. We do not concur with setting specifications and expiry dating using the justification of the b(4) bias based on testing of b(4) lots. Please revise your expiration date to –b(4)--- for Purified TT manufactured at –b(4)-----  Please revise your release specification for Purified TT manufactured at     -b(4)---- to not less than --b(4)--

c.  Please provide a detailed PMC for alignment of the two methods.  Suggested wording is as follows: -----b(4)------------------------------------------------------------- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2. We have the following comments concerning your response to Question 3 of the IR sent 20 March 2012 (stemmed from Question 14 of CR letter dated 21 September 2011). 

a. We recognize that the free PS contents are now reported as a limit when the results are less than the LOQ.  The recalculated result for MenC-TT Batch –b(4)------ for Free Polysaccharide C Content by –b(4)-------------------------------(Table 8).  The LOQ is –b(4)-  Please explain why this result is reported as –b(4)--------------

b. We note that the results for Free TT Content by –b(4)---------------------------------------- are also reported as limits of varying results.  Please confirm that this is for the same reason in that the result is reported as a limit when the result is less than the first calibration point.  For consistency, if the value is below the LOQ it should be reported as < LOQ value.  Please comment.

3. You have responded in an email on 26 April 2012 to Item 13 of the Lot Release Comments originally sent on 20 March 2012 concerning the ---b(4)--------------------------------------------------------------------.  Our comments to your responses are below.

a. GSK would like to propose the addition of toxicity testing –b(4)----- instead of –b(4)-----------.

We concur with the proposal but would appreciate some additional information.  Please confirm that final bulk is your final formulated bulk.  Please provide information on how the specific toxicity testing will be performed on –b(4)-----.

b. GSK will continue toxicity testing on Purified TT at –b(4)---

We concur with this proposal.

c. GSK would like to remove –b(4)- testing on final container.

We do not concur with this proposal.  An exemption from the –b(4)- will require demonstrating that multiple lots of product will reliably pass the test.  There is not enough safety data to approve an exemption from –b(4)- at this time.  Please submit a prior approval supplement containing –b(4)- data from –b(4)- Lots to request an exemption from future testing.

4. You provided a document via email to David Staten on 10 April 2012.  Please clarify the following.

a. You state that PS Content stability testing (Hib, PSC, and PSY) is performed by –b(4)-----------------------.  Please confirm that any final container testing (release or stability) is performed by –b(4)------------saline.

b. You state that specifications of PS content have been set based on--b(4)-------------------.  You are currently evaluating if the specifications are appropriate for reconstitution in saline.  Please explain why you anticipate the specification to change for the different reconstitution methods.

5.         You provided the following PMC in your response dated 15 April 2011.

----b(4)--------- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Revised wording of the PMC is suggested below.  Please provide a date when you anticipate being able to submit the review of specification. ----b(4)--- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.  If this review results in a loosening of the specifications, you will submit the revised specification as a prior approval supplement by XXXX.  If this review results in a tightening of the specifications, you will submit the revised specification as a CBE-30 supplement by XXXX.  If this review results in no changes to the specification, you will submit the data as a PMC Submission by XXXX.