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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, February 6, 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: 06-Feb-2012 04:00 PM           Initiated by FDA? Yes
 
Telephone Number: jody.a.gould@gsk.com
 
Communication Categorie(s):
1. Information Request
 
 
 
Author: KIRK PRUTZMAN
 
Telecon Summary: Reagent/Documentation Request

 

 
FDA Participants: KIRK PRUTZMAN Non-FDA Participants: JODY GOULD Trans-BLA Group: No
 
Related STNs: None Related PMCs: None Telecon Body:
 
Hi Jody,

  
By Kirk Prutzman at 4:10 pm, Feb 06, 2012

 
Please find attached a spreadsheet that contains a list of Reagents and Documentation requested by our product quality reviewers. The documentation can be emailed directly to Karen Campbell (Karen.Campbell@fda.hhs.gov). It does not need to be sent to the BLA.
 
Please contact Karen Campbell when reagents are sent. Please send reagents to:
Karen Campbell
Regulatory Coordinator
Division of Biological Standards and Quality Control (DBSQC) OCBQ/CBER/FDA HFM-680
5516 Nicholson Lane

Kensington, MD 20895 office (301)594-6255
 
 
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

 
Reagents for MenHiberix Drug Product Testing                                                                                                        1/20/2012
If available, please send qualification reports for all reagents, these are needed for the labs performing the testing. Analytical Chemistry Staff –--------(b)(4)-----------
-(b)(4)- Determination of Individual Polysaccharide in Final Container Hib Men CY by -----(b)(4)------
----(b)(4)-----
----(b)(4)------------------------
VERIFY
----(b)(4)-----
----(b)(4)------------------------
VERIFY
----(b)(4)----------------------
----(b)(4)-----
VERIFY
----(b)(4)--------------------------------
----(b)(4)------------------------------
NEED
----(b)(4)--------------------------------
----(b)(4)------------------------------
NEED
 
Hib Type B:Detn. Of molecular distribution of HIB in the combs HIB Men CY by ----(b)(4)---------------------------------   ----(b)(4)-----                      ----(b)(4)-------                                                      NEED    ----(b)(4)-----------                                                 ----(b)(4)------------------------------             VERIFY ---(b)(4)---                                                      ----(b)(4)------------------------------                                                      VERIFY ----(b)(4)---------                                                      ----(b)(4)---------------------------                                                      NEED    ----(b)(4)------------------------------                                                      ----(b)(4)---------------------                                                      NEED    ----(b)(4)------------------------------                              ----(b)(4)-----------                                VERIFY ----(b)(4)----------------
 
Determination of the PSC and PSY content in Final Containers by ----(b)(4)-----
----(b)(4)------------------------------------------------------
 
----(b)(4)-----
NEED
----(b)(4)-----
NEED
----(b)(4)-----------------------------
----(b)(4)-----
NEED
 
Determination of the Polysaccharide Content in HIB Vaccine by ----(b)(4)-----
----(b)(4)----------------
----(b)(4)-------------------------------
VERIFY
----(b)(4)-----
----(b)(4)------------------------------------
VERIFY
 
NEED - used up or unable to locate this material
VERIFY - Have stock, but need verification of suitability due to lack of expiration date
 
 
 
Identity Testing by ---(b)(4)---

 

 
 
 
Hib-TT ---(b)(4)---                                               Lot#

Recommended Dilution/reconstitution volume

----(b)(4)----------------------------               ----(b)(4)--------------------                      ---(b)(4)---                           VERIFY
----(b)(4)----------------------                     ----(b)(4)------------------------------            ----(b)(4)----------------------- VERIFY
----(b)(4)---------------------------------
----(b)(4)-------------------------                  ----(b)(4)------------------------                  ---(b)(4)---                           VERIFY
 
PSC- and PSY-TT ---(b)(4)---
----(b)(4)-----------------------------
----(b)(4)------------------------
--(b)(4)--
VERIFY
----(b)(4)----------------
----(b)(4)-------------------------------
--(b)(4)--
VERIFY
----(b)(4)----------------
----(b)(4)-------------------------------
--(b)(4)--
VERIFY
----(b)(4)---------------------------
 
 
 
----(b)(4)-------------------------------
----(b)(4)------------------------
--(b)(4)--
VERIFY
----(b)(4)---------------------------
 
 
 
----(b)(4)-------------------------------
----(b)(4)------------------------
--(b)(4)--
VERIFY
 
VERIFY - Have stock, but need verification of suitability due to lack of expiration date
If the reagents have been requalified please send documentation and any changes to the recommended dilutions.