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Vaccines, Blood & Biologics

Telecon - Information Request, May 22, 2009- Menveo

System Info - 94871  SHONE, DEANNA   22-May-2009 14:19:01  SHONEDE


Submission Type: Original Application   Submission ID:  125300/0    Office: OVRR  

Meningococcal ACWY Conjugate Vaccine

Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  22-MAY-2009 02:10 AM             Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request


Telecon Summary:
Information Request

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
From:                     Fiore, Cara 
Sent:                      Friday, May 22, 2009 2:10 PM
To:                          ''
Cc:                          Valenti, Elizabeth
Subject:                IR request

Dear Chris,
We have the following Information request for BLA 125300.  There are two sections, one manufacturing and one product.  Please let me know if you have any questions.
Have a nice memorial day!

This is an Information request for BLA 125300, May 21, 2009.

Manufacturing Questions:
Regarding Comparability Protocol (CP), Post-Submission Introduction of a            ----------------------------------------------------------b(4)-----at the Rosia, Italy Facility (Building b(4) (sections 2.3.R.2.2 and 3.2.R.2.2 of the BLA), CBER acknowledges your proposed CBE-30 reporting category.  Please note that CBER reserves the right to upgrade the submission to a PAS due to either your compliance status at the time of the submission, or if validation fails during its execution.  Also note that should significant changes be made to any of the procedures affecting the content of this CP, you must submit a revision to the CP for review and approval prior to execution or you will need to submit the change as a stand-alone PAS.  In addition, please provide the following information:

  1. The CP lacks a description of the proposed -b(4)- components and systems IOQ and PQ studies and information on how the results of these studies will be reported in the implementation supplement.  Please provide this information.
  2. Regarding the --b(4)------------ Cleaning Validation, please provide the rationale for not including b(4) testing.  Also, --b(4)---- testing has been omitted from cleaning validation; please indicate how product contact equipment clean hold times will be established.
  3. Please provide information regarding how -b(4)-- product contact equipment will be sterilized and how these processes will be validated.
  4. There are discrepancies throughout the Media Fill protocol, MediaFill/42/058/---b(4)---/PVP/00, regarding the number of fills required for validation. Some sections of this procedure refer to b(4) media fills while others refer to b(4). Please clarify the number of fills required for validation and amend your protocol accordingly.  Also, please provide the acceptance limits for these media fills.
  5. You state that filling process validation results for- b(4)- will be compared to process validation results obtained for clinical and -b(4)-------------- batches.  Please provide the acceptance criteria for this comparison.  How will this comparison be documented?
  6. Please clarify where visual inspection will be performed for Meningococcal ACWY Conjugate Vaccine final container ---b(4)--- filled on -b(4)-.
  7. Please describe how you will evaluate stability of Meningococcal ACWY Conjugate Vaccine filled on -b(4)-.  Your stability testing panel should include container closure integrity testing, sterility, and final product release tests.

Product questions:

Please provide the following information and documentation:

  1. Regarding the --b(4)----------------------------------, in MenW:CRM Conjugate
    Please provide the validation protocol for --b(4)----------------------- in DS MenW:CRM Conjugate.  The validation protocol for -b(4)------ (Protocol SOP -b(4)- 07.021 VP2Rev 1) was submitted in the DS MenW:CRM Conjugate section (SOP202152).
  2. Regarding the --b(4)----------------------- content, MenA Conjugate, Report 202152 VR2 R3:
    In the evaluation of --b(4)------- accuracy, it states that samples were spiked with MenA standard.  Please clarify if the sample preparation step described in SOP 202152-07, Section 4.3.2, using the --b(4)-------------------- was included as part of this evaluation to allow an assessment of --b(4)--------------- recovery. 
  3. Regarding the --b(4)----------------------- content, MenW and MenY Report b(4) 07.029:
    In the evaluation of accuracy of test for --b(4)-----------------, it states that samples are spiked with “--b(4)-------------------------- of a MenW and MenY solution…”.  Please clarify if the --b(4)---------- sample preparation step described in SOP 202150-02, Section 4.4, was included to allow an assessment of --b(4)----------- recovery.
  4. Regarding Section, 3.2.S. --b(4)---------, SOP 201681, page 8 Analytical Procedures, MenA Polysaccharides:
    “Procedure” section specifies --b(4)--------------------------------------------------------------------------------. Purified polysaccharides should have  --b(4)-----------------------------. Please confirm if this is accurate.  If there is a discrepancy, Please clarify this for all polysaccharides from serogroups A, C, W and Y.
  5. Regarding SOP 202152-07 “Quantitative determination of the --b(4)-------------------- in CRM-MenA glycoconjugates”
    1. Section 4.2 (S1) states that “The ---b(4)--------------------- solution is qualified by determination of the ---b(4)--------------------------”.  Please specify the method and calculations used in this qualification.
    2. Section 3 – -b(4)--------- MenA Polysaccharide Standard”; please describe the source of this material and methodology that was used to characterize and standardize it (or refer to an SOP or protocol in the BLA).
    3. Section 3 – Materials and Equipment; describes --b(4)---------------------------------------------------------------------------”.  Please specify the -b(4)--- of these -b(4)----

7.         Please provide SOPs or detailed descriptions of the following methods, as well as the Validation Documents:

  1. ----b(4)--------------------------
  2. ----b(4)--------------------------
  3. ----b(4)----------------------------------------
  4. ----b(4)--------------------------
  5. ----b(4)--------------------------
  6. Protein concentration b(4) (SOP 201694)
  7. ----b(4)----------------------------------------------
  8. Qualification of Reference Standards  (SOP 203542)    
  9. Purity of CRM197 : Please provide specificity SOP (SOP CRM 07.01 Rev.2) as mentioned in CRM-07-001-vr1-r3.


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