L-Proline-Stabilized Human IgG: Privigen^® 10% for Intravenous Use and Hizentra^® 20% for Subcutaneous Use

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.

KEYWORDS::

• autoimmunity
• idiopathic thrombocytopenic purpura
• IgG
• immune deficiency
• immunoglobulin
• intravenous immunoglogbulin
• ITP
• IVIG
• primary immune deficiency
• proline
• SCIG
• subcutaneous immunoglobulin

Financial & competing interests disclosure

Melvin Berger is an employee of CSL Behring with equity. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.