Table 1. Overview of the different IVIG... | American Society of Hematology

Table 1.

Overview of the different IVIG products tested: Main steps in the production process intended to improve clinical tolerability, the formulation, the percentage change in blood pressure in rats, and the IgG dimer content of the tested lots

IVIG Code	Production Process	Formulation	Status	% Change in MABP	% Change in MABP (Second Lot)	IgG Dimer Content (%)
A	Beta-propiolactone	Liquid	E	1 5		8
B	pH 4/pepsin incub.	Liquid, pH4	E	−5 2	−1 3	6; 5
C	Beta-propiolactone	Liquid	E	−3 0		5
D	Beta-propiolactone	Liquid	L	−3 3	−6 3	12; 15
E	pH 4/pepsin incub.	Freeze-dried	L	−3 5	−8 7	5; 6
F	pH4 incub.	Liquid	E	−6 4		8
G	Beta-propiolactone	Liquid	E	−6 4	−9 2	5; 5
H	DEAE, pH 4/pepsin	Liquid, pH5	E	−5 3	−11 3	7; 8
I	PEG precipitation, DEAE	Liquid	E	−15 8		5
J	DEAE chromatography	Liquid	L	−27 18		10
K	DEAE, pH 5 incub.	Liquid	L	−21 18	−35 19	10
L	pH 4 incub.	Liquid	L	−27	−32 4	8; 8
M	DEAE chromatography	Freeze-dried	L	−31 12		nd
N	DEAE chromatography	Freeze-dried	L	−36 8		6
O	PEG precipitation, DEAE	Liquid, pH 5.5	L	−37 9		10
P	pH 4/pepsin	Freeze-dried	L	−45 3	−46 6	10; 10
IMIG	Cohn II, without further processing	Liquid	L	−59 5		18

IVIG Code	Production Process	Formulation	Status	% Change in MABP	% Change in MABP (Second Lot)	IgG Dimer Content (%)
A	Beta-propiolactone	Liquid	E	1 5		8
B	pH 4/pepsin incub.	Liquid, pH4	E	−5 2	−1 3	6; 5
C	Beta-propiolactone	Liquid	E	−3 0		5
D	Beta-propiolactone	Liquid	L	−3 3	−6 3	12; 15
E	pH 4/pepsin incub.	Freeze-dried	L	−3 5	−8 7	5; 6
F	pH4 incub.	Liquid	E	−6 4		8
G	Beta-propiolactone	Liquid	E	−6 4	−9 2	5; 5
H	DEAE, pH 4/pepsin	Liquid, pH5	E	−5 3	−11 3	7; 8
I	PEG precipitation, DEAE	Liquid	E	−15 8		5
J	DEAE chromatography	Liquid	L	−27 18		10
K	DEAE, pH 5 incub.	Liquid	L	−21 18	−35 19	10
L	pH 4 incub.	Liquid	L	−27	−32 4	8; 8
M	DEAE chromatography	Freeze-dried	L	−31 12		nd
N	DEAE chromatography	Freeze-dried	L	−36 8		6
O	PEG precipitation, DEAE	Liquid, pH 5.5	L	−37 9		10
P	pH 4/pepsin	Freeze-dried	L	−45 3	−46 6	10; 10
IMIG	Cohn II, without further processing	Liquid	L	−59 5		18

The IVIG products are ranked in the order of magnitude of the hypotensive effects and coded with the letters A to P. Each lot was tested in 3 rats at a dose of 250 mg/kg body weight, for 8 products a second lot was tested. The MABP changes are the percentage changes from baseline, 10 minutes after administration of the immunoglobulin preparation (mean and SD of 3 experiments). The status of the products indicates L for licensed and E for experimental preparations. nd = not determined.

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