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Vaccines, Blood & Biologics

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.

Page Last Updated: 12/19/2012
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