Document text
From: Smith, Michael (CBER)
Sent: Wednesday, August 4, 2021 5:27 PM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul
<[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura
<[email protected]>
Subject: RE: [EXTERNAL] STN 125742.0: Comments on LRP template submitted to STN 125742/0.14 on
7/20
Elisa,
I apologize for not including the attachment, please see the attached document.
Regards,
Mike
From: Harkins Tull, Elisa < [email protected]
>
Sent: Wednesday, August 4, 2021 5:19 PM
To: Smith, Michael (CBER) < [email protected] >
Cc: Agha jani Memar, Neda < [email protected] >; Devlin, Carmel M
<[email protected]>; Rohlfing, Paul <[email protected] >; Naik, Ramachandra
<[email protected] >; Gottschalk, Laura < [email protected] >
Subject: Re: [EXTERNAL ] STN 125742.0: Comments on LRP template submitted to STN 125742/0.14 on
7/20
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Hi again M ike,
Your message refers to attachments but there are not attachments to the mail. Can you please send
these when you have a moment? Or alternatively please clarify.
Best regards, Elisa
On Aug 4, 2021, at 4:48 PM, Smith, Michael (CBER) <[email protected]
> wrote:
Elisa,
FDA-CBER-2021-5683-1024820
The review team has the below comments on the lot release protocol (LRP)
template that was submitted to BLA 125742/0.14 on July 20, 2021. The review
team has requested that responses are submitted to the BLA by Wednesday,
August 11, 2021. We anticipate responding to Paul’s clarification questions on
the LRP and samples that were e- mailed us yesterday in the near future.
Throughout document
Please correct the cc: line to STN 125742 -0/2229/FC
Page 1 of 6
Please replace with the attached example (Attachment 1 – Electronic
Protocol Page 1)
Please make sure that the electronic Protocol Number at the bottom of Page 1 matches the number on the eLRP Signature letter.
Information after the Date of Manufacturing line and before the Storage Temperature is optional.
Note: When submitting LRPs electronically, please use a letter formatted per Attachment 2 – eLRP Signature letter. Place this letter before the
electronic protocol.
Page 2 of 6
Components table
• Please add component description for the LNP
Page 3 of 6
• RNA Encapsulation and RNA content.
Please use the RNA content template (Attachment 3) to report the results
• Lipid analysis
Please provide full of the lipid components for the sample,
. Insert the
for the reference standard above the sample lines and label all the
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1024821
The page on which the are provided should include a table
with test date, specifications and results for each lipid content and identity.
Page 4 of 6
• Table 1 (Continued) Filled Vaccine Quality Control Tests
Please remove the abbreviations for
These tests are not performed for the filled vaccine.
• Identity of encoded RNA sequence
Please use the identity test template (Attachment 4) to report the drug
product test results
• In vitro expression
Please use the in vitro expression test template (Attachment 5) to report the drug product test results
• RNA integrity
Please provide that are
RNA for each sample replicate and insert the reference
standard above this line so that the sample lines are not
obscured. Please include clear labels for product and
that were includ ed in the
analysis of each Include the name of the test method, the
specification, date of test and the result on the same page as the
• Bacterial endotoxin
Please use the Limulus Amebocyte Lysate Test template (Attachment 6) to repo rt the drug product endotoxin results.
• Sterility
Method: Please add Method to
Container: Please change 20 mL to
Regards,
(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-2021-5683-1024822
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 P roducts Applications
Tel: 301- 796-2640
[email protected]
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FDA-CBER-2021-5683-1024823