125742 S2 M3 32p8 stability data photostability

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BNT162b2
3.2.P.8.3 .Stability Data
Photostability
PFIZER CONFIDENTIAL
Page 13.2.P.8.3. STABILITY DATA – P HOTOSTABILITY
Data from one stability  study on a BNT162b2 process validation drug product subjected to 
ICH photostability  conditions is presented. Drug product vials were exposed to a light source 
that provides an overall illumination of not less than 1.2 million lux hours and an integrated 
ultraviolet energy  of not less than 200 watt hours/m2, per I CH Q1B. Dark control vials w ere
wrapped in aluminum foil to prevent ex posure to light. All samples w erestored inverted at 2
to 8 °Cfor the duration of the study , as it is not feasible to maintain the samples at the 
intended storage condition of - 90 to -60 °C for this study and the 2 to 8 °C condition is 
considered a worse case exposure condition. Testing wasperformed according to
Table 3.2.P.8.3-1 .
090177e19703f718\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149214
BNT162b2
3.2.P.8.3 .Stability Data
Photostability
PFIZER CONFIDENTIAL
Page 2Table 3.2.P.8.3 -1.Stability Data for Drug Product Lot EL7834 Stored at Photostability Conditions 
Time 
(months)Appearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visible) Appearance (Visible) LNP Size LNP Polydispersity RNA 
EncapsulationRNA Content
Acceptance 
Criteria abWhite to off -white 
suspensionMay contain white to 
off-white opaque, 
amorphous particles7.4 ± 0.5
With Light 
ProtectionWOS Meets 
Without 
Light 
ProtectionWOS Meets 
Time 
(months)HPLC -CAD Cell-based Capillary Gel 
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In vitro Expression RNA Integrity
Acceptance 
Criteria ab
With Light 
Protection
Without 
Light 
Protection
a. 1.2 million lux hours of light and 200 watt hours/m2 of near ultraviolet light at 5 ± 3 °C.
b.  Acceptance criteria in place at time of testing. 
WOS = White to off -white suspension , , S = To be Scheduled, LNP = Lipid Nanoparticle
090177e19703f718\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149215