Document text
From: Smith, Michael (CBER)
Sent: Friday, August 6, 2021 11:31 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: RE: STN 125742.0: IR RE two DP documents
Elisa,
The review team has the below questions regarding the following two drug product (DP) documents 1) Manufacturing Process Development – Process
Development and Characterization and 2) Description of Manufacturing Process and Process Controls – LNP Production and Bulk Drug Product Formulation
[Puurs]. The review team has requested a response by Tuesday, August 10, 2021.
We note the following statement quoted below in your document 3.2.P.2
Manufacturi ng Process Development – Process Development and
Characterization on page 47:
“For more efficient processing, the software at Pfizer Puurs was updated to int
roduce a step, independent of
the selected batch size,
”
T
his
step was validated in coupled with the process
validation for a drug product batch size at Pfizer Puurs (data
submitted to EUA 27034 amendment 116 on March 29, 2021). How ever, the
process validation for the batch size was not executed with this
step. Please clarify that during the routine commercial -scale
manufacturing process, the step is only applied to the
batch scale at Pfi zer Puurs. Please also update the document 3.2.P.3.3
Description of Manufacturing Process and Process Controls – LNP Production and
Bulk Drug Product Formulation [Puurs] to clearly describe at which batch scale the
step will be performed.
Regards,
Mike
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FDA-CBER-2021-5683-1150222
- 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 Va ccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
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FDA-CBER-2021-5683-1150223