Literature DB >> 21322757

L-proline-stabilized human IgG: Privigen® 10% for intravenous use and Hizentra® 20% for subcutaneous use.

Melvin Berger1.   

Abstract

Liquid IgG preparations are preferred over lyophilized preparations because reconstitution is not required. Formation of dimers and aggregates in liquid preparations increases adverse effects and limits the shelf life of most liquid IgG products. Improved understanding of the binding interactions in IgG dimers and aggregates led to the selection of L-proline at pH 4.8 as an excipient that would minimize their formation. CSL Behring has developed the L-proline-stabilized products Privigen®, a 10% IgG solution for intravenous use; and Hizentra®, a 20% solution for subcutaneous use. The former has the longest shelf life of any liquid IgG in the USA--36 months, and the latter is the most concentrated IgG available. These improvements, which translate into improved convenience for pharmacies and patients, were achieved with no compromise in safety, efficacy or tolerability of the products.

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Year:  2011        PMID: 21322757     DOI: 10.2217/imt.10.108

Source DB:  PubMed          Journal:  Immunotherapy        ISSN: 1750-743X            Impact factor:   4.196


  9 in total

1.  Privigen immune globulin intravenous (human), 10% liquid.

Authors: 
Journal:  P T       Date:  2011-08

2.  Open-label study on treatment with 20 % subcutaneous IgG administration in polymyositis and dermatomyositis.

Authors:  Maria Giovanna Danieli; Romina Moretti; Simona Gambini; Luca Paolini; Armando Gabrielli
Journal:  Clin Rheumatol       Date:  2014-01-07       Impact factor: 2.980

3.  Management of a pregnant woman with common variable immunodeficiency and previous reactions to intravenous IgG administration.

Authors:  Maria Giovanna Danieli; Romina Moretti; Lucia Pettinari; Simona Gambini
Journal:  BMJ Case Rep       Date:  2012-12-17

Review 4.  Immune globulin subcutaneous (human) 20%: in primary immunodeficiency disorders.

Authors:  Paul L McCormack
Journal:  Drugs       Date:  2012-05-28       Impact factor: 9.546

Review 5.  Manufacture of immunoglobulin products for patients with primary antibody deficiencies - the effect of processing conditions on product safety and efficacy.

Authors:  Albert Farrugia; Isabella Quinti
Journal:  Front Immunol       Date:  2014-12-23       Impact factor: 7.561

6.  Reduction of Isoagglutinin in Intravenous Immunoglobulin (IVIG) Using Blood Group A- and B-Specific Immunoaffinity Chromatography: Industry-Scale Assessment.

Authors:  Simon Gerber; Annette Gaida; Nicole Spiegl; Sandra Wymann; Adriano Marques Antunes; Ibrahim El Menyawi; Brigitte Zurbriggen; Alphonse Hubsch; Martin Imboden
Journal:  BioDrugs       Date:  2016-10       Impact factor: 5.807

7.  Association of blood IgG with tumor necrosis factor-alpha and clinical course of chronic lymphocytic leukemia.

Authors:  David E Spaner; Robertson Venema; Justin Huang; Peter Norris; Alan Lazarus; Guizhi Wang; Yonghong Shi
Journal:  EBioMedicine       Date:  2018-08-30       Impact factor: 8.143

8.  Effect of IVIG Formulation on IgG Binding to Self- and Exo- Antigens In Vitro and In Vivo.

Authors:  Susann Cattepoel; Annette Gaida; Alain Kropf; Marc W Nolte; Reinhard Bolli; Sylvia M Miescher
Journal:  PLoS One       Date:  2016-08-25       Impact factor: 3.240

9.  Replacement and Immunomodulatory Activities of 20% Subcutaneous Immunoglobulin Treatment: A Single-Center Retrospective Study in Autoimmune Myositis and CVID Patients.

Authors:  Maria Giovanna Danieli; Jacopo Umberto Verga; Cristina Mezzanotte; Irene Terrenato; Silvia Svegliati; Maria Beatrice Bilo; Gianluca Moroncini
Journal:  Front Immunol       Date:  2022-01-17       Impact factor: 7.561

  9 in total

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