
Record of Telephone Conversation, April 27, 2011 - Flublok

 

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

Product: Influenza Vaccine

Applicant: Protein Sciences Corporation

Telecon Date/Time: 27-Apr-2011 04:15 PM        Initiated by FDA? Yes

Telephone Number:

Communication Category: Information Request

Author: TIMOTHY FRITZ

Telecon Summary:

1) CBER would monitor the stability of the lyophilized 2009 H1 rHA and that PSC would thus not need to conduct a formal stability study for this material. 2) PSC’s recent amendments addressing –b(4)------------------------------ and fill validation concerns. 

FDA Participants: Timothy Fritz, Rakesh Pandey

 

Non-FDA Participants: Penny Post, Manon Cox

 

Telecon Body:

 Background:

 

In a February 22, 2011 telecon, CBER requested that PSC submit a plan to monitor the stability of PSC’s 2009 H1 rHA (--b(4)-------------) lyophilized by CBER as a potential reference antigen. PSC submitted a stability plan as Amendment 42 to STN 125285 on March 31, 2011.

 

Discussion:

 

CBER informed PSC that CBER would monitor the stability of the lyophilized 2009 H1 rHA and that PSC would thus not need to conduct a formal stability study for this material. However, CBER indicated that PSC should monitor ring diameters of the rHA reference antigen as part of trending and tracking of SRID method characteristics and parameters. Additionally, CBER indicated that PSC should establish criteria for acceptable ring diameter. PSC acknowledged the request and indicated that it had previously provided CBER with ring diameter acceptance criteria in its SRID SOPP QT77.

 

CBER indicated that PSC should evaluate whether the SRID assay using the potential H1 rHA reference antigen is stability indicating. PSC asked how this should be done. CBER indicated that a previous protocol submitted by PSC to monitor the stability of rHA at various times and temperatures would be acceptable. PSC acknowledged that they knew the protocol to which CBER was referring.

 

CBER said that it was trying to provide PSC with comments regarding PSC’s recent amendments addressing –b(4)----------------------------------- and fill validation concerns. CBER said that it would need to review the results of the b(4) study being conducted by    -b(4)------------------------------ for PSC before CBER could provide comments. CBER asked if PSC could provide an update on when these study results would be available. PSC indicated that the study had encountered some difficulty during the sample testing and that it was not sure when the results would be available.

 

Action Items:

 

PSC asked whether they should prepare protocols for CBER review for –b(4)--------------- experiments to test for –b(4)----------------- in the event that ---b(4)--------------------------------------------------experiments were unsuccessful. CBER said that it would discuss this internally and provide a response to PSC as soon as possible.

 

PSC also asked if and when CBER would inform PSC that CBER had approved the 2009 H1 rHA reference antigen. CBER said that it would discuss this internally and provide a response to PSC as soon as possible.

 