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Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen © ) stabilized with L‐proline
Author(s) -
Cramer M.,
Frei R.,
Sebald A.,
Mazzoletti P.,
Maeder W.
Publication year - 2009
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/j.1423-0410.2008.01143.x
Subject(s) - proline , monomer , polyclonal antibodies , chemistry , chromatography , antibody , biochemistry , immunology , organic chemistry , medicine , amino acid , polymer
Background and Objectives IgPro10 (Privigen © ) is a new liquid intravenous immunoglobulin (IVIG) product that is formulated with 250 mM L‐proline at pH 4·8. A 3‐year study was performed to assess its stability. Materials and Methods Physicochemical, biological and immunological parameters of Privigen were assessed during storage under controlled conditions over up to 36 months at 25°C. Results Privigen was shown to be stable after storage for 3 years at room temperature (25°C). Of all parameters tested, only a few showed changes during storage. The appearance of the solution complied with the specifications given by the European Pharmacopeia over the full study period, with a single exception. The IgG fraction in Privigen displayed high purity (≥ 98%), which did not change during storage over 36 months. No relevant amounts of aggregated IgG molecules were formed in Privigen samples and the ratio between monomers and dimers shifted slightly towards the equilibrium over time. Testing of reference antibody contents and the Fc function demonstrated that the biological activity and effector functions of Privigen were preserved over the full study period of 36 months. Conclusion Thirty‐six months room temperature stability of Privigen was achieved at pH 4·8 with an innovative formulation containing the physiological stabilizer L‐proline.