Document text
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Silver Spring, MD 20993
STN 125742/0 Test Memo – H. Wang 1
To: STN 125742/0
From : Hsiaoling Wang , Ph.D., Analyst , CBER/ OCBQ/D BSQC/ LACBRP
Through: Tao Pan, Ph.D., Team Lead, CBER/OCBQ/DBSQC/LACBRP
Kori Francis, Acting Lab Chief , CBER/OCBQ/DBSQC/LACBRP
Maryna Eichelberger, Ph.D., Division Director, CBER/OCBQ/DBSQC
Mary A. Malarkey, Office Director , CBER/OCBQ
Applicant: BioNTech
Product: COMIRNATY (COVID- 19 mRNA Vaccine)
Subject : Test results of lipid nanoparticle size and polydispersity index for COMIRNATY drug
product
The determination of COMIRNATY drug product (DP) lipid nanoparticle size and polydispersity
index (PDI) was performed on August 17, 2021 per
DP s ample s from three lots and the assay control
(a DP lot) were prepared at
.
The test results obtained by DBSQC and those from the firm are summarized in the tables below.
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150331
2 Determination of s ize
Lot CBER size (nm) CBER RSD Firm size (nm)
Control
FC3181
FC3184
FD0809
Determination of PDI
Lot CBER PDI Firm PDI
Control
FC3181
FC3184
FD0809
The average size of the standard measured by DBSQC was with RSD of ,
meeting the acceptance criteria of respectively. The RSDs for
the control and samples both met the same acceptance criteria of
The proposed DP specifications are for and for PDI. CBER test
results are similar to those of the firm and meet these criteria .
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150332