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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, July 16, 2008 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product: Influenza Vaccine
Applicant: Protein Sciences Corporation
Telecon Date/Time: 16-Jul-2008 03:27 PM        Initiated by FDA? Yes
Communication Category: Information Request
Author: RAKESH PANDEY
Telecon Summary: Assay validations
FDA Participants: Rakesh Pandey
Non-FDA Participants: Manon Cox
Telecon Body:
 
Here is another request, but related to Assay validations information in the BLA:
 
1. In the Validation Final Report Protocol 95026.00 for the In Vitro Assay for                     Adventitious Viral Contamination ----------(b)(4)------------------- the first table on page 6 of 30 contains a column "%Confidence." What is the definition of the %Confidence in this table and how it was calculated.
2. In the Quality validation report - QVRQT0042 page 11 of 44 contains plot of the QVPQT 0042 Linearity Experiment. This plot demonstrates obvious deviation from the linearity in the area of smaller rHA concentrations. It is well known fact that the single criterion based only on the high coefficient of determination is not sufficient to demonstrate linearity. If you believe that this visible deviation from linearity is small enough to be still acceptable given intended use of the assay, please provide detailed justification.
3. Please provide justification for the formula for calculation of the Limit Of Detection on page 5 of 7 of Quality Control Report R-08-005, 25-Mar-2008.