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Results from seven studies of four subcutaneous IgG preparations in patients with primary immune deficiencies show that the incidence of infection is inversely related to the steady-state IgG level. Maintaining higher IgG levels may be beneficial, and no given level is necessarily adequate for all patients. © Springer Science+Business Media, LLC 2011.

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. © 2011 Future Medicine Ltd.

Berger M.,CSL Behring LLC
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons | Year: 2012

Since the introduction of tacrolimus, small-bowel and multivisceral transplantion has increased to 100-200/year in the United States. The intestine carries more passenger lymphocytes than other organs, and bidirectional trafficking of lymphocytes and other immunocytes begins as soon as the vascular clamp is released. Because of ischemia-reperfusion injury and exposure to ligands for Toll-like receptors from the lumen, the innate immune system of the graft is activated, causing inflammation which must be brought under control by regulatory cells. Inclusion of the liver in the allograft favors graft acceptance, but the mechanism of this effect has not been determined. Anti-HLA and other anti-donor antibodies clearly play a major role in determining the long-term fate of the graft, as reflected in 5-year graft survival. Development of new (de novo) HLA antibodies and/or increases in their titers or function-especially the ability to bind C1q and activate complement increase the risk of graft loss. Monitoring antidonor antibody production and the use of new therapies including complement inhibitors will contribute to increasing success of SBT. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

Berger M.,CSL Behring LLC | Berger M.,Case Western Reserve University
Current Opinion in Allergy and Clinical Immunology | Year: 2011

Purpose of Review: Subcutaneous IgG (SCIG) is becoming more popular, but there is still uncertainty about efficacy and optimal dosing. This review discusses recent pharmacokinetic studies and applications of SCIG therapy, and its efficacy in the context of emerging understanding of the relationship between dosing and efficacy of both intravenous IgG (IVIG) and SCIG replacement therapy for primary immunodeficiency diseases. Recent Findings: Three preparations of IgG have been licensed in the US in the past year. Their bioavailabilities are 65-70% of that of IVIG. Pooled analyses show that the efficacy of SCIG in preventing infections is proportional to the steady-state levels achieved, and similar to that of IVIG. Pharmacokinetic studies allow estimation of doses that will yield desired serum levels with both IVIG and SCIG, and when switching from one route to another. Summary: Pooled analyses show that at equivalent total doses, weekly SCIG results in steady-state levels 10-20% higher than troughs on monthly IVIG. For most patients, the choice between routes should be based on individual preference, and the regimen should be individualized to achieve the desired outcomes. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.

CSL Behring L.L.C. | Date: 2015-07-17

A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Separation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitable for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.

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