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From: Smith, Michael (CBER)
Sent: Tuesday, August 17, 2021 2:13 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin,
Carmel M <[email protected]>; Rohlfing, Paul <[email protected]>
Subject: STN 1 25742.0: IR on DS
Elisa,
The review team has the below questions on the drug substance and they have requested a response as soon as possible and no later than COB Wednesday,
August 18, 2021.
1. In your drug substance (DS) manufacturing process validation studies
performed at both Pfizer and Pfizer , the process parameter
for the was validated to be within the range of
However, in your documents Section 3.2.S.2.2 Manufacturing
Process Andover and Secti on 3.2.S.2.4 Controls of Critical Steps and
Intermediates - Manufacturing Process, the is
described as . Please align the acceptance range of this
process control parameter in all the documents based on your validati on
study results.
2. Please update the Tables 3.2.P.3.4 -1 in Sections 3.2.P.3.4 Process Step
– – Puurs and Kalamazoo, to include the validated
for DS using
based on your qualification/validation
data submitted to BLA 125742 amendment 33 in response to our August 3, 2021 Information Request query 4.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
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FDA-CBER-2021-5683-1150267
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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FDA-CBER-2021-5683-1150268