BABYBIG Powder for solution for injection Ref.[9962] Active ingredients: Botulinum antitoxin

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

BabyBIG, Botulism Immune Globulin Intravenous (Human) (BIG-IV), is a solvent-detergent-treated, sterile, lyophilized powder of immunoglobulin G (IgG), stabilized with 5% sucrose and 1% albumin (human). It contains no preservative. The purified immunoglobulin is derived from pooled adult plasma from persons who were immunized with recombinant botulinum vaccine for serotypes A and B (rBV A/B) and selected for their high titers of neutralizing antibody against botulinum neurotoxins type A and B. All donors were tested and their sera found to be negative for antibodies against the human immunodeficiency virus and the hepatitis B and hepatitis C viruses.

The pooled plasma was fractionated by cold ethanol precipitation of the proteins according to the Cohn/Oncley method, modified to yield a product suitable for intravenous administration. [24,25] Several steps in the manufacturing process have been validated for their ability to inactivate or remove viruses that may not have been detected in the Source Plasma.[1,26-29]

These include Cohn/Oncley fractionation (Fraction I through Supernatant III Filtrate); nanofiltration through one 75-nm and two 35-nm filters; and solvent/detergent viral inactivation. These viral reduction steps have been validated in a series of in vitro experiments for their capacity to inactivate and/or remove Human Immunodeficiency Virus type 1 (HIV-1) and the following model viruses: bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; mouse encephalomyelitis virus (MEMV) as a model for hepatitis A virus; and pseudorabies virus (PRV), feline calicivirus (FCV), and Sindbis virus to cover a wide range of physicochemical properties in the model viruses studied. Total mean log10 reductions range from 4.63 to greater than 16 log10 as shown in the following table.

Process Step Mean Reduction Factor (log10)
Enveloped Viruses (size in nm) Non-Enveloped Viruses (size in nm)
Sindbis (60-70) HIV-1 (80-100) PRV (120-200) BVDV (40-60) MEMV (22-30) FCV (35-39)
Cohn/Oncley fractionation 6.6>9.44>10.376.254.06Not done
Nanofiltration ≥6.84Not doneNot done≥5.4Not done≥6.92
Solvent/detergent treatmentNot done>4.51>5.53>4.850.57* Not done
Cumulative Reduction Factor (log10) ≥13.44>13.95>15.9≥16.54.63≥6.92

* Included hydrophobic chromatography after solvent/detergent treatment.

Additional testing performed with bovine parvovirus (as a model for parvovirus B19) showed a mean cumulative reduction factor of greater than 7.34 log10 for Cohn/Oncley fractionation and solvent/detergent treatment followed by hydrophobic chromatography. A mean cumulative reduction factor of 2.55 log10 was observed for removal of porcine parvovirus by nanofiltration.

When reconstituted with Sterile Water for Injection USP, each cubic centimeter (milliliter) contains approximately 50 ± 10 mg immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg sucrose; 10 mg albumin (human); and approximately 20 × 10-3 mEq sodium. The reconstituted solution should appear colorless and translucent [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5)].

Dosage Forms and Strengths

100 mg ± 20 mg lyophilized immunoglobulin per single-dose vial.

How Supplied

NDC 68403-1100-6, 100 mg ± 20 mg lyophilized immunoglobulin single-dose vial individually packaged in a carton, supplied with 2 mL Sterile Water for Injection USP for reconstitution.

Drugs

Drug Countries
BABYBIG United States

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