A new liquid, intravenous immunoglobulin product (IGIV 10%) highly purified by a state‐of‐the‐art process

Teschner, Wolfgang; Butterweck, Harald Arno; Auer, Wilfried; Muchitsch, Eva-Maria; Weber, Alfred; Liu, S.-L.; Wah, Po-Shing; Schwarz, Hans‐Peter

doi:10.1111/j.1423-0410.2006.00846.x

Cited by 39 publications

(39 citation statements)

References 40 publications

(45 reference statements)

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“…As IVIG is manufactured from plasma samples from thousands of healthy donors, the WNV-neutralizing Abs in IVIG are the result of successful immune responses against WNV infection. Two 10% IVIG lots (Gammagard Liquid; Baxter Healthcare Corp) (19,25) 1A) were fractionated into the respective IgG subclasses (Table 1) by using pH gradient elution from a protein A-conjugated affinity column in a procedure similar to one described previously (21). Fractions were diluted to identical protein concentrations of 30 mg/ml and tested for in vitro WNV neutralization using essentially a method described previously (18).…”

mentioning

confidence: 99%

Human IgG Subclasses: In Vitro Neutralization of and In Vivo Protection against West Nile Virus

Hofmeister

Planitzer

Farcet

et al. 2011

J Virol

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West Nile virus (WNV)-neutralizing intravenous immune globulins (IVIG)were fractionated into IgG subclasses, and the contribution of each subclass to in vitro neutralization of and in vivo protection against WNV was evaluated. The results indicate that IgG1 (i) is the main subclass induced following WNV infection of humans, (ii) contained nearly all the in vitro WNV neutralization capacity, and (iii) mediates effector functions in vivo that render it superior to other subclasses in protection against WNV. The importance of human IgG1 indicates that a candidate WNV vaccine should induce an immune response that includes WNV-specific IgG1.West Nile virus (WNV), a flavivirus which has become endemic in North America (1) and has now also been recognized as a major public health concern in Europe (6), causes mostly asymptomatic infections (in ϳ80% of cases), and less than 1% of WNV-infected persons develop neuroinvasive disease (7). There are currently no WNV-specific antiviral drugs available, and treatment of patients is limited to supportive care. To optimize efficacy of a potential vaccine, an understanding of the factors involved in successful WNV clearance after infection of humans is important. Some aspects of the immune response to WNV infection have been studied in detail, especially the affinities and specificities of WNV-neutralizing antibodies (Abs), properties which are crucial for effective virus neutralization (5,8,16,26). During these investigations, it became evident that the murine immune response to WNV differs to some degree from that of humans; e.g., the strongly neutralizing Abs that recognize an epitope on the lateral ridge of domain III of the WNV envelope protein in mice are generated far less frequently in the human immune response (16,27). Reports of protective immune responses following the induction of WNV-specific Abs without virus-neutralizing properties highlighted the involvement of Ab-mediated effector responses such as Ab-dependent cellular cytotoxicity, complement activation, and Ab interaction with Fc-␥ receptors (Fc␥Rs) in protection and immunity (3,14,15). The apparent importance of effector functions beyond virus neutralization in host defense renders an understanding of the profile of human IgG subclasses induced following WNV infection and the respective contributions of the subclasses to in vivo protection particularly interesting. The four human IgG subclasses, IgG1 to IgG4, differ in their affinities for Fc␥Rs and therefore in their abilities to induce effector responses (2). In addition, IgG subclass-dependent effects on in vitro virus neutralization were shown recently for another flavivirus, dengue virus (20). Although accumulating evidence highlights the differential involvement of IgG subclasses in the humoral response against flavivirus infection, no information on the contributions of the different human IgG subclasses to WNV neutralization in vitro and, more importantly, their contributions to in vivo protection is currently available.In this work, we used intraveno...

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mentioning

confidence: 99%

Human IgG Subclasses: In Vitro Neutralization of and In Vivo Protection against West Nile Virus

Hofmeister

Planitzer

Farcet

et al. 2011

J Virol

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“…Раз-личий между лиофилизатом и раствором для инфузий, а также между препаратами разной концентрации и различных производителей, не выявлено [8][9][10][11][12]. Тем не менее имеются некоторые преимущества 10 % растворов по сравнению с 5 %, что позволяет делать выбор в их пользу.…”

Section: том 5 Volunclassified

Intravenous high-dose immunotherapy: practical recommendations for use in the treatment of neurological disimmune diseases

Супонева¹,

Гришина²

2015

Neuromuscular Diseases

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16Лекции и обзоры 4'2015 ТОМ 5 VOL. 5Нервно-мышечные Б О Л Е З Н И Neuromuscular DISEASES Дизиммунные заболевания периферического ней-ромоторного аппарата (острые и хронические дизим-мунные полиневропатии, миастения гравис и миасте-ноподобные заболевания, миозиты и полимиозиты и др.) поражают зачастую лиц трудоспособного возра-ста и в большинстве своем достаточно инвалидизиру-ющие. Проблема терапии данной группы заболеваний нервной системы занимает особое место и требует отдельного рассмотрения.К основным видам лечения дизиммунных заболе-ваний в неврологии, доказавшим свою эффективность в контролируемых исследованиях, относят корти-костероидные препараты (КСП), программный плаз-маферез (ПП), а также высокодозную внутривенную иммунотерапию (ВВИ). Выбор того или иного метода определяется множеством факторов, основными из которых являются диагноз, наличие противопока-заний и высоких рисков развития побочных эффектов, доступность и безопасность того или иного вида лече-ния. При этом следует отметить, что КСП неэффек-тивны и не показаны при синдроме Гийена-Барре (СГБ) [1] и мультифокальной моторной нейропатии (ММН) [2], а также в лечении отдельных форм хрони-ческой воспалительной демиелинизирующей поли-невропатии (ХВДП); кроме того, длительная терапия КСП чревата развитием множества побочных эффек-тов. Проведение ПП, в свою очередь, требует соответ-ствующего оснащения клиники, наличия подготов-ленных медицинских кадров, а также отсутствия таких состояний, как эрозивно-язвенное поражение желу-дочно-кишечного тракта, менструации, тромбоцито-пении и анемии, обострения геморроя и др., способ-ных привести к кровотечению на фоне необходимого при проведении ПП введения высоких доз гепари-

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“…On the other hand one 1,200 L column of a conventional ion exchange column as described for Gammagard Liquid purification (Teschner et al, 2007) with a loading capacity of the resin of 100 mg IgG/mL can bind 120,000 g IgG. Only 43 runs would be necessary to process the equivalent of 1 million liters of plasma.…”

Section: Cost-effectiveness Of Affinity Chromatography For the Purifimentioning

confidence: 99%

“…Most of the immunoglobulin products from human plasma are manufactured conventionally combining precipitation and ion exchange chromatography (Ballow et al, 2003, Stein et al, 2009, Teschner et al, 2007, but there are also attempts to introduce new techniques like expanded bed chromatography (Anspach et al, 1999, Barnfield Frej et al, 1997, Hubbuch et al, 2001 or affinity chromatography in the manufacturing of plasma derived therapeutic proteins (Suomela, 1980). In view of the limitations of affinity chromatography the successful implementation is reported for low aboundant plasma proteins (Weber et al, 2011) and hyperimmune IgG preparations (Bryant et al, 2005) which are produced in lower amounts and given at lower doses intramuscularly.…”

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 new liquid, intravenous immunoglobulin product (IGIV 10%) highly purified by a state‐of‐the‐art process

Cited by 39 publications

References 40 publications

Human IgG Subclasses: In Vitro Neutralization of and In Vivo Protection against West Nile Virus

Human IgG Subclasses: In Vitro Neutralization of and In Vivo Protection against West Nile Virus

Intravenous high-dose immunotherapy: practical recommendations for use in the treatment of neurological disimmune diseases

Affinity Chromatography for Purification of IgG from Human Plasma

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