Document text
From: Smith, Michael (CBER)
Sent: Friday, June 25, 2021 3:23 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: IR RE LRP template and samples & reagents
Elisa,
The review team has the below Information Request for you regarding the lot
release protocol (LRP) template and samples & reagents.
LRP template IR for STN 125742/0:
Please submit a lot release protocol template for COVID -19 mRNA Vaccine for
CBER review by COB Friday, July 9, 2021. Please include the assays performed
and acceptance criteria for the drug product.
Sample and Reagent IR for 125742/0:
Drug Substance (DS) Please p rovide 50 aliquots (200 µL aliquots preferred) of DS from three different
lots and the following reagents in sufficient quantity to perform 50 independent
tests for the following DS assays:
1. 5’ – Cap assay
i. The current assay control (PF -07305885 DS reference material or
equivalent as stated in TM100010578)
2. Poly(A) Tail
i. The current internal control as stated in TM100010379
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150171
Drug Product (DP)
Please provide 170 vials of DP per lot from three different DP lots and the
following reagents for the following DP release assays:
1. LNP Size
i. Current assay control - an amount (in 3 aliquots) adequate to perform 10
independent tests
2. RNA Encapsulation and RNA Content
i. Reference Standards A and B - 50 vials of each standard or enough to
perform 50 tests
3. Lipid identities
i. Reference PF -07302048 - 20 vials
ii. Four (4) lipid standards - 5 grams of each
4. Identity of encoded RNA sequence
50 vials of each reagent OR enough to perform 50 tests
i. Positive PCR Control: PF -07305885 DS or equivalent as stated in
TM100010407
ii. Positive Control: PF -07302048 DP or equivalent as stated in
TM100010407
5.
In Vitro Expression Potency assay
i.
ii. Reference Standards, Qualified - 50 vials
of each or enough of each to perform 50 tests
6. RNA Integrity
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150172
i. Reference Material - 50 vials of each reagent OR enough to
perform 50 tests
Documentation 1. Please provide Certificates of Analysis for all reagents
2. Please provide results of the assays listed for the DS lots and DP lots
submitted to CBER
The samples and reagents should be shipped to:
Emnet Yitbarek
Food and Drug Administration Center for Biol ogics Evaluation and Research
Division of Biological Standards and Quality Control 10903 New Hampshire Avenue
WO75, G -650
Silver Spring, MD 20993
Contact Marie Anderson at 240 -402- 6292 ( [email protected] ) for
questions regarding the request and to provide tracking number of the
shipment(s).
We request that these samples, reagents and documentation be sent by July 9, 2021, or notify CBER by then when the shipment(s) can be expected.
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
(b) (4)
FDA-CBER-2021-5683-1150173
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-2021-5683-1150174