Document text
From: Smith, Michael (CBER)
Sent: Wednesday, August 4, 2021 11:00 AM
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 potency assay for determination of IVE by flow cytometry
Elisa,
The review team has two questions for you regarding the potency assay for
determination of in vitro expression (IVE) by flow cytometry. The review team has requested a response by Friday, August 6, 2021.
The following comments pertain to the Report for Co-validation of Test Method TM100010380 – Determination of the In -vitro Expression of PF-
07302048 (BNT162b2 Construct, Drug Product) by Flow Cytometry (VAL100147509 ).
1. You reported an overall percent relative standard deviation (%RSD) of in Table 12-5 on Page 14 of the report. However,
our calculation results in an overall %RSD using
the Mean S1+% data from this table. Please expla in how you
calculated the overall %RSD for
2. We note that, in Tables 14-1 and 14 -2 on Page 21 of the report, the
mean S1+ (%) results from compared to
the results from . This trend becomes more
, which may indicate some
systematic difference between . Please
comment and explain why you consider reproducibility to be acceptable given this observation.
Regards,
Mike
- Please confi rm receipt of this e-mail and let us know if you have any
questions.
Mike Smith, Ph.D.
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150209
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]
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS
ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a
person authorized to deliver the document to the addressee, you are hereby notified that any review, disclo sure, dissemination, copying, or other action
based on the content of this communication is not authorized. If you have
received this document in error, please immediately notify the sender immediately by e- mail or phone.
FDA-CBER-2021-5683-1150210