
Record of Telephone Conversation, January 17, 2012 - Flublok

 
 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR

Product:

Influenza Vaccine

Applicant:

Protein Sciences Corporation

Telecon Date/Time: 17-Jan-2012 02:31 PM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Advice

Author: TIMOTHY FRITZ

Telecon Summary:

--b(4)------------------ investigation of FluBlok is not complete.

FDA Participants: Timothy Fritz

Non-FDA Participants: Penny Post

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

From:                    Fritz, Timothy

Sent:                      Tuesday, January 17, 2012 2:31 PM

To:                         Penny Post (penny.post@proteinsciences.com)

Subject:                 CBER comments regarding PSC 09-16-2011 b(4) response

 

Importance:           High

Dear Dr. Post-

 

CBER has reviewed PSCs September 16, 2011, response to Comment 4 of CBERs May 27, 2011 Information Request. CBERs comments are provided below.

 

GENERAL COMMENTS:

PSC has provided responses to CBER comments in the IR letter dated May 27, 2011 and submitted results from PSCs and b(4)------------------------------------ studies to address the nature of the b(4)---------- produced from Spodoptera frugiperda-derived expresSF+ cells and present in the drug product. PSC concludes that the overall results indicate b(4)-------------------------and therefore no further studies need to be done. We do not agree with this assessment. Our review of the information and data provided in the submission indicates that the results do not resolve the question of whether b(4)------------------------------------------------------------- and therefore it remains unclear whether the      --b(4)--------- in the product represents a risk to vaccine recipients.

 

We recognize PSCs efforts to understand the nature of b(4)---------------. We also acknowledge that insect cell b(4) is a novel area of research with little information regarding its biological properties. Nevertheless, it is critical to either eliminate the b(4)--- or resolve the nature of the b(4)----- in the final drug product so that the risk, if any, associated with b(4)------ can be evaluated. Possible approaches toward resolving this issue might include investigating strategies in the manufacturing processes to b(4)---------------------- from the final drug product, and/or evaluating potential risk associated with the presence of b(4)----------------. CBER is willing to have further scientific discussions to help understand and resolve this issue. Specific comments related to the data provided by PSC (Amendment 47, September 16, 2011) in response to CBERs comment 4 in the IR letter dated May 27, 2011 are listed below.

 

 

SPECIFIC COMMENTS TO PSCs RESPONSES TO CBER IR LETTER COMMENT 4:

 

--b(4)-----------

 

--b(4)----------------------------------------------------------------------------------------------------------------. 

 

--b(4)------------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

COMMENTS: The results are acceptable.

 

 

b. Submit results of ongoing studies on concentrated drug product samples.

 

----b(4)--- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- --b(4)----- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)----- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)---- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

 

Evaluation of SF+ cell substrate b(4)-------

 

a. Submit the results on b(4)----- ---------------------------------------------------------------------------------------------

 

--b(4)--- -------------------------------------------------------------- completed their investigation and submitted a final report in Appendix 2. They analyzed b(4)------- from

 

 

1 Page determined to be not releasable: b(4)

 

 

   

--b(4)---- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)---- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)--- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)-- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

--b(4)--- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

If you have any questions, please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-796-2640.

 

Thank you,

Timothy A. Fritz, Ph.D. 
Microbiologist 
FDA/CBER/OVRR/DVRPA/CMC2 
WOC2 HFM-478
1451 Rockville Pike 
Rockville, MD 20852 
Phone: 301-796-2640 
Fax: 301-827-1597

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