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From: Smith, Michael (CBER)
Sent: Friday, August 6, 2021 7:26 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] ov>
Subject: STN 125742.0: 3 questions RE measurement of endotoxins using the
LAL procedures
Elisa,
The review team has the below three question for you r egarding the
measurement of endotoxins using the LAL
procedures. They have requested a response as soon as possible and no later
than Friday,
August 13, 20211.
1. Your procedure for measuring endotoxin in Drug Product (DP) includes a
” step. While you provide data demonstrating the
does not impact the activity of endotoxin that is
, you have not provided data to evaluate the potential endotoxin- like
activity of the
Please provide data to address potential
endotoxin- like activity of .
2. You state that the step is performed to
is the usual approach to .
Please provide data from a
).
3. From the data generated in the preceding request, we ask that you identify a
for testing DP within the ,
. Please use this information to establish the
endotoxin limit and establish a specification for DP endotoxin activity levels
for samples that are . Please comment and provide a date by
which results from the test using samples can be included for DP lot release, together with the endotoxin results for samples
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FDA-CBER-2021-5683-1150224
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-2021-5683-1150225