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From: Smith, Michael (CBER)
Sent: Friday, July 9, 2021 4:46 PM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>
Subject: STN 125742.0: IR RE the validation of the RNA Integrity by capillary gel electrophoresis (CGE)
method
Elisa,
The review team has three questions for you regarding the validation of the RNA
Integrity by capillary gel electrophoresis (CGE) method - see below.
We are reviewing your Biologics License Application (STN 125742/0) submitted on May 18, 2021, for your BNT162b2 vaccine and have the following Information
Request (IR) regarding the validation of the RNA Integrity by capillary gel
electrophore sis (CGE) method (VAL100136603- v2). Please respond by providing
the requested data or your plans to address these requests, by July 23, 2021.
1. Please describe the spiked materials used for evaluating the
2. T
he acceptance criterion for the assay Range evaluation is stated as
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150179
Pl
ease comment and provide
additional data to support your proposed acceptance criterion for the RNA
integrity Range evaluation.
3. You stated on Page 31 that the assay quantitatio n limit (QL) was
determined from the results
study. Please explain.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications Tel: 301- 796-2640
[email protected]
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hone.
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150180