
Meeting Mintues, May 29, 2012 - Flucelvax


 
 
 

Meeting ID#:                         BLA 125408     

                                  

Product Name:                       Influenza Vaccine (MDCK Cells)

    

Sponsor:                                 Novartis Vaccines and Diagnostics, Inc.

 

Meeting Date/Time:             29-May-2012; 3:00 pm

 

Meeting Chair/Leader:         Karen Campbell

 

Meeting Recorder:                Karen Campbell

 

CBER Attendees:                 

Brenda Baldwin

Timothy Nelle

Zhiping Ye

Haruhiko Murata

Lokesh Bhattacharyya

Muhammad Shahabuddin

Hyesuk Kong

Catherine Poole

Karen Campbell

 

Brief Background 

 

Optaflu is an inactivated, cell-culture derived influenza virus vaccine. 

This is an electronic submission in the eCTD format in Global Submit.

This submission is due 21-Sep-2012

 

Purpose of Meeting 

To discuss in-support testing, lot release and the testing plan.

 

Meeting Discussion

I. Testing – In-support and post-licensure

 

For in-support testing DBSQC received monovalent bulks for potency testing. This testing has been performed and the RPM/chair have the results to send to Novartis. They will send the results along with the comments on the lot release protocol template.

We have not seen trivalent bulk for in-support testing yet.

 

For in-support and post licensing testing of the trivalent bulk ---------(b)(4)---------------------- will be tested. There are no chemical tests that should be performed by DBSQC.

 

The following questions need to be answered about testing in DBSQC

 
•Are the testing requirements, including the methods to be used adequately defined, documented and understood? All attendees agreed
•Does the laboratory have the capability and resources to meet the requirements? All attendees agreed
• Has the appropriate test method been selected? Is the test method capable of meeting the requirements of the product release program specified by the product office in the testing plan? All attendees agreed

II. Lot release protocol review

 

We reviewed the DBSQC lot release protocol comments that had been sent prior to the meeting. DVP reviewers had not had a chance to do a thorough review. They agreed with the changes we had questions for them on.

 

On page 7 – Safety tests the DBSQC reviewers were OK unless DVP reviewers had concerns. We will ask Novartis to include information on inactivation of the virus, date and conditions. DVP reviewers agreed.

 

On page 8 - ----(b)(4)------- Antigen test – DVP reviewers agreed that if this is submitted in the strain change supplement it doesn’t need to be on all lot release protocols submitted.

 

On page 11 – Residual infectious influenza virus – DBSQC and DVP had questions in the information request pertaining to this test, we are waiting on their response before clarifying what we want to see in the lot release protocol. This information is expected by the end of the month.

 

DBSQC had a question on whether we wanted them to test for host cell protein. DVP CMC reviewers felt that since total protein has to be ---(b)(4)---- and their process for removing host cell protein seems robust they did not feel this testing was necessary.

 

Seed information (other than lot numbers) does not need to be included in the lot release protocol. This is similar to what we agreed to recently for FluMist.

 

III. Other issues – There were no other issues discussed

 

Action Items 

 

1. Karen will remind the DVP CMC reviewers to complete their review of the lot release protocol template once the information on the residual infectious influenza virus is received.

 

2. If the information on the residual infectious influenza virus is received by the end of May we should have our lot release protocol review and comments ready to be sent by June 6.