Biochemical characterization and stability of immune globulin intravenous 10% liquid (Panzyga^®)

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• 作者：Christa Mersich^a ; ^{christa.mersich@octapharma.com} ; Karin Ahrer^a ; Andrea Buchacher^a ; Thomas Ernegger^a ; Guido Kohla^b ; Christoph Kannicht^b ; Katharina Pock^a ; Jü ; rgen Rö ; misch^a
• 关键词：Panzyga® ; IVIG 10% liquid ; Purity ; Integrity ; Stability ; Safety
• 刊名：Biologicals
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：45
• 期：Complete
• 页码：33-38
• 全文大小：384 K
• 卷排序：45

文摘

Panzyga® is a new glycine-formulated immune globulin intravenous 10% liquid for the treatment of patients suffering from immunodeficiencies and autoimmune diseases.Panzyga® is a high purity, native and functional IgG product with an IgG subclass distribution equivalent to normal plasma. The levels of hemagglutinins and accompanying plasma proteins (including IgA and IgM) are low. Potential procoagulant activity is not detectable. Functional activity of the IgG was demonstrated by opsonophagocytosis and receptor binding assays. Dynamic light scattering measurements and fluorescent dye binding were used to characterize the integrity of the IgG molecule.Panzyga® is stable under refrigerated storage for at least two years regarding all assessed physicochemical and functional parameters; it can also be stored at room temperature for at least twelve months within its total shelf-life.