Document text
From: Smith, Michael (CBER)
Sent: Wednesday, August 18, 2021 2:36 PM
To: Rohlfing, Paul <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin,
Carmel M <[email protected]>; Harkins Tull, Elisa <[email protected]>
Subject: RE: [EXTERNAL] RE: STN 125742.0: IR on DS
Paul,
The review team provided me the below response to your e- mail:
The proven acceptance range (PAR) of 0 -35 minutes for the
is acceptable. Meanwhile, we acknowledge that a target range of
for the will remain in the Andover batch records
for both manufacturing sites
Regards,
Mike
From: Rohlfing, Paul <Paul.Rohlfing@pfizer .com >
Sent: Wednesday, August 18, 2021 10:07 AM
To: Smith, Michael (CBER) < [email protected] >; Harkins Tull, Elisa
<[email protected]>
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >; Ag hajani Memar, Neda <[email protected]>; Devlin,
Carmel M <[email protected] >; Ro hlfing, Paul <[email protected]>
Subject: [EXTERNAL] RE: STN 125742.0: IR on DS
Importance: High
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
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Mike,
Regarding the comments on we would ask the review team to consider the
relevant supporting information provided in 3.2.S.2.6 Manufacturing Process Development-Process Development and Characterization of the BLA. We have provided relevant information
from that document below.
The was studied as a experiment
with a range of . The study design and results are described 3.2.S.2.6
(b) (4)
(b) (4)
(b) (4)
(b) (4)
b)
(4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b)
(4)
(b) (4)
FDA-CBER-2021-5683-1150272
Manufacturing Process Development -Process Development and Characterization and the
results are shown in the table below copied from the BLA.
Please confirm receipt of this email. I am availab le to discuss this issue further with you or
members of the review team in order to reach quick resolution.
Regards,
Paul Rohlfing
Executive Director GCMC Vaccines
Pfizer
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150273
- mobil e
(919) 566-4927 - office
[email protected]
THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION
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From: Smith, Michael (CBER) <[email protected] >
Sent: Tuesday, August 17, 2021 2:13 PM
To: Harkins Tull, Elisa < [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >; Agh ajani Memar, Neda <[email protected]>; Devlin,
Carmel M <[email protected] >; Roh lfing, Paul <[email protected]>
Subject: [EXTERNAL] STN 125742.0: 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, the is
described as . Please align the acceptance range of this
process control parameter in all the documents based on your validation 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 validat ed
for DS using both the
based on your qualification/validation
(b)
(4)
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(b)
(4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b)
(4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b)
(4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150274
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.
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-2021-5683-1150275