A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Baygam Online, Description, Chemistry, Ingredients - Immune Globulin
Baygam Online, Description, Chemistry, Ingredients - Immune Globulin
DESCRIPTION
Immune Globulin (Human) BayGam® treated with solvent/detergent is a sterile
solution of immune globulin for intramuscular administration; it contains no
preservative. BayGam is prepared by cold ethanol fractionation from human plasma.
The immune globulin is isolated from solubilized Cohn fraction II. The fraction
II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate
(TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent
(sodium cholate), the solution is heated to 30°C and maintained at that temperature
for not less than 6 hours. After the viral inactivation step, the reactants
are removed by precipitation, filtration and finally ultrafiltration and diafiltration.
BayGam is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32
M glycine. BayGam is then incubated in the final container for 21-28 days at
20-27°C.
The removal and inactivation of spiked model enveloped and non-enveloped viruses
during the manufacturing process for BayGam has been validated in laboratory
studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant
virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model
Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Hepatitis B
virus and the Herpes viruses; and Reo virus type 3 (Reo) was chosen to model
non-enveloped viruses and for its resistance to physical and chemical inactivation.
Significant removal of model enveloped and non-enveloped viruses is achieved
at two steps in the Cohn fractionation process leading to the collection of
Cohn Fraction II: the precipitation and removal of Fraction III in the processing
of Fraction II + IIIW suspension to Effluent III and the filtration step in
the processing of Effluent III to Filtrate III. Significant inactivation of
enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction
II with TNBP/sodium cholate.
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