Fc function of a new intravenous immunoglobulin product: IGIV 10% triple virally inactivated solution.
Vox Sang
; 91(3): 256-63, 2006 Oct.
Article
en En
| MEDLINE
| ID: mdl-16958839
ABSTRACT
BACKGROUND AND OBJECTIVES:
Baxter AG has developed a new liquid intravenous immunoglobulin product [Immune Globulin Intravenous (IGIV) 10%] using a new manufacturing procedure. A modified Cohn fractionation and ion exchange chromatography is used to produce an IgG solution with no alterations to the Fc region. Three dedicated virus reduction steps are included solvent-detergent treatment, nanofiltration, and incubation at low pH and elevated temperature in final formulation. We applied the reference method of the European Pharmacopoeia (EP) together with a flow-cytometric binding assay for the evaluation of the Fc function of the new product. MATERIALS ANDMETHODS:
The EP reference method was done as described in the EP. The flow-cytometric method measured binding of IgG to Fc receptors of human monocytic THP-1 cells after exclusion of apoptotic cells.RESULTS:
Sixteen lots of the new product expressed Fc functions between 84% and 110% when analysed with the EP reference method and Fc-binding activities between 82% and 121% when determined by the flow-cytometric method.CONCLUSION:
All tested lots of the new product demonstrated a high level of Fc activity and met the requirements of the EP for Fc function.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Inmunoglobulina G
/
Fragmentos Fc de Inmunoglobulinas
/
Inmunoglobulinas Intravenosas
Tipo de estudio:
Evaluation_studies
Límite:
Humans
Idioma:
En
Revista:
Vox Sang
Año:
2006
Tipo del documento:
Article
País de afiliación:
Austria