Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process

Trejo, Sebastián A.; Hotta, Jun‐ichi; Lebing, Wytold R.; Stenland, Christopher J.; Storms, Rachel E.; Lee, D. C.; Li, H.; Petteway, Stephen R.; Remington, Kathryn Martin

doi:10.1046/j.1423-0410.2003.00279.x

Cited by 62 publications

(43 citation statements)

References 22 publications

(24 reference statements)

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“…Laboratory findings did not reveal any important changes in parameter between the different infusion rates, and there were no signs of hemolysis. As described in detail previously, the manufacturing process for this immunoglobulin preparation enables the maintenance of the proteins in solution during purification, providing gentler treatment of the immune globulin molecules [21,20]. This process may contribute to the observed tolerability of this IGIV preparation even at the highest rate used here, 0.14 mL/kg/min, despite a dose of 1 g/kg body weight.…”

Section: Discussionmentioning

confidence: 90%

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Safety and tolerability of a novel chromatography‐based intravenous immunoglobulin when administered at a high infusion rate in patients with immune thrombocytopenic purpura

Bussel

Kim

2006

American J Hematol

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Intravenous immunoglobulin (IGIV) therapy is generally considered to be a safe and effective treatment for idiopathic thrombocytopenic purpura (ITP). The usual initial treatment dose is 1-2 g/kg body weight, which results in an extended infusion time, significantly impacting patients' day-to-day activities. Two crossover studies assessed the safety and tolerability of a novel IGIV preparation (IGIV-C; Gamunex 1 , 10%) when infused at rates ranging from 0.08 mL/kg/min (the standard maximum licensed rate) to 0.14 mL/kg/min in patients with ITP. The first study included 28 patients and 3 infusion rates; 0.08, 0.11, and 0.14 mL/kg/min. The second study included 8 patients and 2 infusion rates; 0.08 and 0.14 mL/kg/min were evaluated. The incidence of infusion-related adverse events was similar for all infusion rates. Headache was the most commonly reported infusion-related adverse event. The incidence, combined for Studies 1 and 2, was 14.7% (n 5 34), 18.2% (n 5 22), and 19.4% (n 5 31) of patients, for each infusion rate of 0.08, 0.11, and 0.14 mL/kg/min, respectively. The majority were mild in severity. None of the other drug-related, treatment-emergent events were serious; most were mild, in spite of the higher rate of fluid loading over a shorter period of time for patients infused at 0.14 mL/kg/min. There were no clinically important changes in parameters that distinguished between infusion rates; there were no signs of hemolysis. The results suggest that IGIV-C infused at rates up to 0.14 mL/kg/min in patients with ITP is well tolerated. Am. J. Hematol. 82:192-198, 2007. V V C 2006 Wiley-Liss, Inc.

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Section: Discussionmentioning

confidence: 90%

“…All patients participating in this study received IGIV-C, 10% (Gamunex 1 ), an IGIV product manufactured using a novel chromatography-based manufacturing method and formulated without sucrose [18][19][20][21]. The demographic profiles of patients participating in both studies are summarized in Table I.…”

Section: Methodsmentioning

confidence: 99%

Safety and tolerability of a novel chromatography‐based intravenous immunoglobulin when administered at a high infusion rate in patients with immune thrombocytopenic purpura

Bussel

Kim

2006

American J Hematol

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“…During the last decades the control of the donors, the test of the plasma donations and the incorporation of dedicated virus reduction steps into the manufacturing schemes was regularly improved to a very high standard (Furuya et al, 2006, Kreil et al, 2004, Poelsler et al, 2008, Stucki et al, 2008, Trejo et al, 2003 in order to reduce the risk of virus transmission with blood products as often reported in the early days (Bresee et al, 1996, Farrugia & Poulis, 2001). …”

Section: State Of the Art Igg Preparations And Their Usementioning

confidence: 99%

Affinity Chromatography for Purification of IgG from Human Plasma

Hofbauer¹,

Bruckschwaiger²,

Butterweck³

et al. 2012

Affinity Chromatography

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“…A key group of scale-down papers has been published by scientists and engineers in companies and is concerned with studies to validate the removal of viruses and prions (Cabatingan, 2005;Jakubik et al, 2004;Rathore et al, 2005;Thyer et al, 2006;Trejo et al, 2003;Zhou et al, 2006). Here the need for what is termed ''qualified scale-down'' arises because biosafety would not allow large-scale trials.…”

Section: Recent Scale-down Studiesmentioning

confidence: 99%

Micro biochemical engineering to accelerate the design of industrial‐scale downstream processes for biopharmaceutical proteins

Titchener‐Hooker

Dunnill

Hoare

2008

Biotech & Bioengineering

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The article examines how a small set of easily implemented micro biochemical engineering procedures combined with regime analysis and bioprocess models can be used to predict industrial scale performance of biopharmaceutical protein downstream processing. This approach has been worked on in many of our studies of individual operations over the last 10 years and allows preliminary evaluation to be conducted much earlier in the development pathway because of lower costs. It then permits the later large scale trials to be more highly focused. This means that the risk of delays during bioprocess development and of product launch are reduced. Here we draw the outcomes of this research together and illustrate its use in a set of typical operations; cell rupture, centrifugation, filtration, precipitation, expanded bed adsorption, chromatography and for common sources, E. coli, two yeasts and mammalian cells (GS-NSO). The general approach to establishing this method for other operations is summarized and new developments outlined. The technique is placed against the background of the scale-down methods that preceded it and complementary ones that are being examined in parallel. The article concludes with a discussion of the advantages and limitations of the micro biochemical engineering approach versus other methods.

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Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process

Abstract: This comprehensive approach to pathogen safety provides the new immunoglobulin manufacturing process with a detailed, yet realistic, assessment of the risk of transmission of infectious pathogens.

Cited by 62 publications

References 22 publications

Safety and tolerability of a novel chromatography‐based intravenous immunoglobulin when administered at a high infusion rate in patients with immune thrombocytopenic purpura

Safety and tolerability of a novel chromatography‐based intravenous immunoglobulin when administered at a high infusion rate in patients with immune thrombocytopenic purpura

Affinity Chromatography for Purification of IgG from Human Plasma

Micro biochemical engineering to accelerate the design of industrial‐scale downstream processes for biopharmaceutical proteins

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