Document text
BNT162b2
3.2.P.3.2 Batch Formula
PFIZER CONFIDENTIAL
Page 13.2.P.3.2. BATCH FORMULA
The target drug product batch size
Table 3.2.P.3.2 -1presents the unit formula for one
liter of formulated bulk drug product soluti on, as well as batch formula s for representative
batch size s of
Table 3.2.P.3.2 -1. Batch Formula for BNT162b2 Bulk Drug Product
Nam e of Ingredients Reference to
StandardUnit Formula
per 1 L
(g)
BNT162b2 d rug substance In-house
specification0.5
ALC -0315 In-house
specification7.17
ALC -0159 In-house
specification0.89
DSPC In-house
specification1.56
Cholesterol Ph. Eur. and/or
USP-NF3.1
Sucrose Ph. Eur. , USP-
NF
Sodium chloride Ph. Eur. , USP-
NF6
Potassium chloride Ph. Eur. and/or
USP-NF0.15
Dibasic s odium phosphate,
dihydrateaPh. Eur. , USP-
NF1.08
Monobasic potassium phosphatebPh. Eur. and/or
USP-NF0.15
Water for I njection Ph. Eur. , USP-
NFq.s.
a. Dibasic sodium phosphate, dihydrate is named as disodium phosphate dihydrate in the Ph. Eur.
b.Monobasic potassium phosphate is named as potassium dihydrogen phosphate in the Ph. Eur.
Abbreviations:
ALC -0315 = ((4 -hydroxybutyl)azanediyl)bis(hexane -6,1-diyl)bis(2 -hexyldecanoate)
ALC -0159 = 2 -[(polyethylene glycol) -2000] -N,N-ditetradecylacetamide
DSPC = 1,2 -Distearoyl -sn-glycero -3-phosphocholine
q.s. = quantum satis, meaning as much as is sufficient
090177e19700a16c\Approved\Approved On: 12-May-2021 08:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150805