Local tolerance and stability up to 24 months of a new 20% proline-stabilized polyclonal immunoglobulin for subcutaneous administration

Maeder, W; Lieby, Patricia; Sebald, Andrea; Spycher, M. A.; Pedrussio, Renzo; Bolli, Reinhard

doi:10.1016/j.biologicals.2010.11.004

Cited by 23 publications

(15 citation statements)

References 23 publications

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“…13 The content of fragments was ≤4%, which is below the specified limits of ≤10%. anti-measles, anti-polio type 1, anti-parvovirus B19, and diphtheria antitoxin), which remained above or significantly exceeded specified levels.…”

Section: Formulationmentioning

confidence: 87%

“…13 In contrast to other subcutaneous IgG preparations, it is stabilized with l-proline (250 mmol/L), a nonessential natural amino acid found at high level in human plasma.…”

Section: Formulationmentioning

confidence: 99%

“…anti-measles, anti-polio type 1, anti-parvovirus B19, and diphtheria antitoxin), which remained above or significantly exceeded specified levels. 13 Direct comparison of these results is not possible because the studies were not powered to determine dose-related differences in clinical outcomes. Moreover, a number of factors, such as country-specific medical practices for diagnosing infections, cultural differences relating to absence from work/school, and the higher number of children in the European Figure 3.…”

Section: Formulationmentioning

confidence: 99%

“…13 Currently, 16% IgG preparations, such as Vivaglobin, are infused at 10-20 mL per hour. 6,8 Hizentra was infused at a median infusion rate of 25.3 mL/hour in the recent European study, and rates as high as 35.0 mL/hour were used in 34.8% of patients.…”

Section: Reduced Infusion Durationmentioning

confidence: 99%

“…13 First, the need to maintain refrigeration facilities at hospitals or doctor's offices is obviated for many countries, and storage at home is easier for patients, especially when several months worth of immunoglobulin is delivered at once. …”

Section: Convenient Storage At Room Temperaturementioning

confidence: 99%

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Subcutaneous immunoglobulin replacement therapy with Hizentra®, the first 20% SCIG preparation: a Practical approach

Jolles

Sleasman

2011

Adv Therapy

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Section: Formulationmentioning

confidence: 87%

“…13 In contrast to other subcutaneous IgG preparations, it is stabilized with l-proline (250 mmol/L), a nonessential natural amino acid found at high level in human plasma.…”

Section: Formulationmentioning

confidence: 99%

Section: Formulationmentioning

confidence: 99%

Section: Reduced Infusion Durationmentioning

confidence: 99%

Section: Convenient Storage At Room Temperaturementioning

confidence: 99%

See 3 more Smart Citations

Subcutaneous immunoglobulin replacement therapy with Hizentra®, the first 20% SCIG preparation: a Practical approach

Jolles

Sleasman

2011

Adv Therapy

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The osmotic pressure of highly concentrated monoclonal antibody solutions: Effect of solution conditions

Binabaji

Rao

Zydney

2013

Biotech & Bioengineering

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The behavior of monoclonal antibodies at high concentrations is important in downstream processing, drug formulation, and drug delivery. The objective of this study was to evaluate the osmotic pressure of a highly purified monoclonal antibody at concentrations up to 250 g/L over a range of pH and ionic strength, and in the presence of specific excipients, using membrane osmometry. Independent measurements of the second virial coefficient were obtained using self-interaction chromatography, and the net protein charge was evaluated using electrophoretic light scattering. The osmotic pressure at pH 5 and low ionic strength was >50 kPa for antibody concentrations above 200 g/L. The second virial coefficients determined from the oncotic pressure (after subtracting the Donnan contribution) were in good qualitative agreement with those determined by self-interaction chromatography. The second virial coefficient decreased with increasing ionic strength and increasing pH due to the reduction in intermolecular electrostatic repulsion. The third virial coefficient was negative under all conditions, suggesting that multi-body interactions in this system are attractive. The virial coefficients were essentially unaffected by addition of sucrose or proline. These results have important implications for the analysis of protein-protein interactions in downstream processing at high protein concentrations.

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Naturally Occurring Antibodies/Autoantibodies in Polyclonal Immunoglobulin Concentrates

Späth

Lutz

2012

Advances in Experimental Medicine and Biology

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It was a long way from the use of hyperimmune animal sera for the treatment of toxin-producing infections to the production of polyclonal, polyspecific human immunoglobulin preparations and the use of NAbs as therapeutic tools for autoimmune and inflammatory diseases. Some highlights of the development of knowledge in blood fractionation techniques, basic science and clinical wisdom are reviewed in this chapter. Proudly we mention the outstanding contribution of Swiss scientists and clinicians in the development of IVIG as clinical tool for some otherwise untreatable diseases or taking advantage of its low adverse event profile in long-term treatment of other chronic autoimmune and inflammatory diseases. This chapter summarizes some of the characteristics and the effects in humans of NAbs which are present in IgG concentrates. We call attention to the fact that the human data remain, at least in part, incomplete, among others because even with the most efficient large-scale techniques available not more than approximately 50% of the total IgG in plasma can be fractionated into an immunoglobulin G concentrate.

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Local tolerance and stability up to 24 months of a new 20% proline-stabilized polyclonal immunoglobulin for subcutaneous administration

Cited by 23 publications

References 23 publications

Subcutaneous immunoglobulin replacement therapy with Hizentra®, the first 20% SCIG preparation: a Practical approach

Subcutaneous immunoglobulin replacement therapy with Hizentra®, the first 20% SCIG preparation: a Practical approach

The osmotic pressure of highly concentrated monoclonal antibody solutions: Effect of solution conditions

Naturally Occurring Antibodies/Autoantibodies in Polyclonal Immunoglobulin Concentrates

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