Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen<sup>©</sup>) stabilized with L‐proline

Cramer, Matthias; Frei, R.W.; Sebald, Andrea; Mazzoletti, P.; Maeder, W

doi:10.1111/j.1423-0410.2008.01143.x

Cited by 27 publications

(16 citation statements)

References 18 publications

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“…The eluate was adjusted with 0.5 M Tris base (pH 8.0) to pH 4.5 and concentrated up to 16 mg/ml protein. Human plasma IgG preparations (IgPro10, Privigen) were prepared as described previously (30). Monoclonal IgAC5 specific for S. flexneri LPS serotype 5a was produced via hybridoma cells as described previously (31).…”

Section: Preparation Of Human Plasma Iga- Igm-and Igg-enrichedmentioning

confidence: 99%

Reconstituted Human Polyclonal Plasma-derived Secretory-like IgM and IgA Maintain the Barrier Function of Epithelial Cells Infected with an Enteropathogen

Longet

Vonarburg

Lötscher

et al. 2014

Journal of Biological Chemistry

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Section: Preparation Of Human Plasma Iga- Igm-and Igg-enrichedmentioning

confidence: 99%

Reconstituted Human Polyclonal Plasma-derived Secretory-like IgM and IgA Maintain the Barrier Function of Epithelial Cells Infected with an Enteropathogen

Longet

Vonarburg

Lötscher

et al. 2014

Journal of Biological Chemistry

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“…12,[15][16][17][18] Privigen is a 10% liquid preparation of polyvalent human IgG formulated for intravenous administration. Stabilization with L-proline at pH 4.8 is unique in that it fully preserves IgG functional activity without a requirement for refrigeration for up to 36 months, 19 and minimizes the formation of IgG dimers during storage. 20,21 We report herein the results of the pediatric subpopulation of an open-label Phase III study utilizing Privigen for the treatment of patients with PID.…”

Section: Efficacy and Safety Assessmentsmentioning

confidence: 99%

Efficacy and Safety of Privigen in Children and Adolescents With Primary Immunodeficiency

Church¹,

Borte²,

Hassan³

et al. 2009

Pediatric Asthma, Allergy & Immunology

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The objective of this prospective, open-label, single-arm, Phase III study was to assess the effi cacy and safety of Privigen ® , the fi rst 10% liquid intravenous immunoglobulin stabilized with L-proline, in patients with primary immunodefi ciency. As part of a larger study, 19 children (3-11 years) and 12 adolescents (12-15 years) received Privigen 200-741 mg/kg intravenously for 12 months at a maximum infusion rate of 8 mg/kg/min. Thirteen patients received infusions at up to 12 mg/kg/min as part of an extension study. The primary endpoint was the annual rate of acute serious bacterial infections (aSBIs) per patient. Privigen was effective, as indicated by the annual rate of aSBI of 0.12 per patient (upper 1-sided 99% CI 0.499) in 3-to 11-year-olds and 0.10 (CI 0.642) in 12-to 15-year-olds. Three patients experienced 1 aSBI each, but did not discontinue treatment. The annual rate of all infections (including aSBIs) per patient was 4.63 in children and 2.42 in adolescents. The annual rate of days missed from school/day care was 11.5 days in children and 4.8 days in adolescents, consistent with the low annual rate of hospitalization (0.53 days and 0 days, respectively). Privigen administration was well-tolerated even at high infusion rates. The proportion of infusions with temporally associated AEs for the entire pediatric population was 0.18 (upper 1-sided 95% CI 0.221). One patient experienced serious AEs considered related to study drug and was withdrawn. Privigen was effective in sustaining a low incidence of infections, including aSBIs, and showed a good tolerability profi le, with adverse events typical of disease and treatment.

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“…Octanoic acid precipitation purifies the immunoglobulins, and anion exchange chromatography removes the non-IgG immunoglobulins and polishes the IgG fraction [55,56]. These steps eventually lead to 99% IgG purity.…”

Section: Specific Ivig Productsmentioning

confidence: 99%

“…The formulation minimizes the formation of IgG degradation, aggregation, and denaturation. Its unique feature is its enhanced long-term stability at room temperature up to 36 months [55,56,58]. The minimization of IgG dimer formation is important, given the improved clinical tolerance observed with a reduced IgG dimer formation [56,58].…”

Section: Specific Ivig Productsmentioning

confidence: 99%

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Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Saeedian

Randhawa

2014

Int Arch Allergy Immunol

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Objective: The expansion of immunoglobulin replacement to multiple disease entities marks a decade-long advancement in immune therapy. Parallel to its extension, the characteristics and composition of immunoglobulin products have diversified. The aim of this study was to summarize a 20-year comprehensive literature review of currently commercially available immunoglobulin products, particularly examining individual product properties in a comparative format. Data Sources/Study Selections: The literature review was performed using PubMed and Ovid, screening a time span of 2 decades. Both authors reviewed the obtained articles for acceptable quality, and the selection was narrowed down based on criteria for randomized clinical and therapeutic trials. Results: Product-specific characteristics in terms of purification strategy, stabilizers, composition, and viral inactivation were found among the immunoglobulin products investigated. Such differing characteristics manifest in their variable clinical safety and efficacy as assessed by the comparative product analysis. In subgroups of patients, subcutaneous immunoglobulin therapy may be an alternative to intravenous immunoglobulin (IVIG) therapy with an equal efficacy and a lower number of systemic adverse events. Conclusion: Only few comprehensive clinical synopses are available to clearly demonstrate the differences in IVIG products despite the widespread clinical use of the therapy. This review defines significant characteristics of individual immunoglobulin products, noting important differences in product development and application and allowing informed clinical decisions to match a product with patients' risk factors and comorbidity. This balanced approach to gammaglobulin replacement therapy is imperative to produce the highest clinical efficacy and lowest number of adverse events.

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Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen^©) stabilized with L‐proline

Abstract: Thirty-six months room temperature stability of Privigen was achieved at pH 4.8 with an innovative formulation containing the physiological stabilizer L-proline.

Cited by 27 publications

References 18 publications

Reconstituted Human Polyclonal Plasma-derived Secretory-like IgM and IgA Maintain the Barrier Function of Epithelial Cells Infected with an Enteropathogen

Reconstituted Human Polyclonal Plasma-derived Secretory-like IgM and IgA Maintain the Barrier Function of Epithelial Cells Infected with an Enteropathogen

Efficacy and Safety of Privigen in Children and Adolescents With Primary Immunodeficiency

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

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Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen©) stabilized with L‐proline

Abstract: Thirty-six months room temperature stability of Privigen was achieved at pH 4.8 with an innovative formulation containing the physiological stabilizer L-proline.

Cited by 27 publications

References 18 publications

Reconstituted Human Polyclonal Plasma-derived Secretory-like IgM and IgA Maintain the Barrier Function of Epithelial Cells Infected with an Enteropathogen

Reconstituted Human Polyclonal Plasma-derived Secretory-like IgM and IgA Maintain the Barrier Function of Epithelial Cells Infected with an Enteropathogen

Efficacy and Safety of Privigen in Children and Adolescents With Primary Immunodeficiency

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Contact Info

Product

Resources

About

Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen^©) stabilized with L‐proline