Antibody production: Polyclonal-derived biotherapeutics

Newcombe, Claire; Newcombe, Anthony R.

doi:10.1016/j.jchromb.2006.07.004

Cited by 60 publications

(43 citation statements)

References 39 publications

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“…In contrast, there are a wealth of PAbs with a range of different specificities and affinities. Currently, polyclonal Ab therapeutics are widely used in medicine for the neutralization of viruses and toxins and for replacement therapy in patients with immunoglobulin deficiencies [5]. This emphasises the need for Abs that allow for the elution of bound Abs using fairly mild elution reagents.…”

Section: Introductionmentioning

confidence: 99%

Application of an ELISA-elution Assay to Dissociate Digoxin-antibody Complexes in Immunoaffinity Chromatography

Lin

Wang

et al. 2010

Scandinavian Journal of Immunology

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In this study, we used a modified enzyme‐linked immunosorbent assay (ELISA)‐elution technique as a screening tool to select specific elution conditions. We examined 12 different elution conditions for the removal of antibodies from a complex on an ELISA plate; 0.2 mol/l glycine‐HCl (pH 2.5), 1.0 mol/l acetic acid (pH 2.5), 25% methanol (pH 2.5) and 3 mol/l NaSCN showed a higher elution efficiency. We conducted affinity chromatography with these four conditions for the purification of anti‐digoxin antibodies from hyperimmune sera with a digoxin‐specific column using ω‐aminoalkyl derivatives of Sepharose 4B, whose elution efficiency was similar to that of ELISA. We also monitored the relative specific activities during elution from the digoxin‐specific column. The optimum, general‐purpose dissociation reagent for this immunoaffinity system was identified as 25% methanol (pH 2.5) with an elution efficiency and relative specific activity of 88.40% and 62.25%, respectively. The high purity of the purified antibodies was demonstrated with sodium dodecyl sulphate‐polyacrylamide gel electrophoresis.

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Section: Introductionmentioning

confidence: 99%

Application of an ELISA-elution Assay to Dissociate Digoxin-antibody Complexes in Immunoaffinity Chromatography

Lin

Wang

et al. 2010

Scandinavian Journal of Immunology

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“…One incarnation of the passive approach is the use of intravenous immune globulin (IGIV) such as Gamunex (Talecris Biotherapeutics, North Carolina) or Gammagard (Baxter, Illinois), which are 10% w/v liquid suspensions of purified human IgG [38]. Numerous studies have reported both in vitro [39,40] and in vivo efficacy of IGIV treatment in murine models and patients with AD [41][42][43][44].…”

Section: Passive Intravenous Immunization With Enriched Immune Globulinmentioning

confidence: 99%

Immunotherapy in Secondary and Light‐Chain Amyloidosis

Wall

2010

Protein Misfolding Diseases

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“…9 This paper models a synthetic Protein A based chromatographic capture of antibodies from sheep serum, an option that is being considered by Protherics UK Limited (Blaenwaun, Ffostrasol, Llandysul, Wales, UK) as an initial purification step for the manufacture of the FDA-approved rattlesnake anti-venom CroFab  . 10,11 The synthetic adsorbent step was simulated using the Thomas model, 12 which was then used to predict the amounts of antibody that are captured and lost upon application of the ovine serum to the column. Assumed data values used to populate the model were obtained from Protherics.…”

Section: Illustrative Industrial Case Studymentioning

confidence: 99%

Global sensitivity analysis for the determination of parameter importance in the chromatographic purification of polyclonal antibodies

Chhatre

Francis²,

Newcombe³

et al. 2007

J of Chemical Tech & Biotech

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BACKGROUND: The financial and technical challenges currently being faced by the pharmaceutical industry have prompted the development of computer models that rapidly evaluate manufacturing strategies for commercialscale drug production. The utility of a model is enhanced by the application of sensitivity analysis techniques (SA), which seek to quantify the relative importance of different input variables. Among several SA methods available, global sensitivity analysis (GSA) provides a powerful means of ranking inputs based on the contribution that each makes towards the variance of a model. To demonstrate the value of the approach, this paper describes the application of GSA to a mathematical model of the synthetic adsorbent-based chromatographic capture of antibodies from ovine serum, a strategy being considered by Protherics UK Limited for production of an FDA-approved rattlesnake anti-venom.

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Antibody production: Polyclonal-derived biotherapeutics

Cited by 60 publications

References 39 publications

Application of an ELISA-elution Assay to Dissociate Digoxin-antibody Complexes in Immunoaffinity Chromatography

Application of an ELISA-elution Assay to Dissociate Digoxin-antibody Complexes in Immunoaffinity Chromatography

Immunotherapy in Secondary and Light‐Chain Amyloidosis

Global sensitivity analysis for the determination of parameter importance in the chromatographic purification of polyclonal antibodies

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