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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.

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