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Standardization of antibody preparations for use in immunogenicity studies: a case study using the World Health Organization International Collaborative Study for Islet Cell Antibodies.

Mire-Sluis, A; Gaines Das, R and Lernmark, Åke LU (2003) In Developments in Biologicals 112. p.153-163
Abstract
The immunogenicity of biological therapeutic products is currently a high profile regulatory and biotechnology industry issue. The immune responses raised against biotechnology products range from the benign, to affecting product efficacy, to those that have serious deleterious clinical impact. The most widely used marker of immunogenicity is the detection and measurement of antibody responses induced in vivo to a product. This relies on assays that are sensitive and robust. In order to assess the parameters of an assay during its design, development and validation, it is extremely useful to have a reference standard to compare assay results. However, immune responses lead to polyclonal antibody preparations that can vary by affinity and... (More)
The immunogenicity of biological therapeutic products is currently a high profile regulatory and biotechnology industry issue. The immune responses raised against biotechnology products range from the benign, to affecting product efficacy, to those that have serious deleterious clinical impact. The most widely used marker of immunogenicity is the detection and measurement of antibody responses induced in vivo to a product. This relies on assays that are sensitive and robust. In order to assess the parameters of an assay during its design, development and validation, it is extremely useful to have a reference standard to compare assay results. However, immune responses lead to polyclonal antibody preparations that can vary by affinity and avidity. This makes it extremely difficult to select a preparation that will behave similarly in different test systems and against different antibody samples. The case example of the WHO standardization of islet cell antibodies illustrates the difficu (Less)
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author
publishing date
type
Contribution to journal
publication status
published
subject
in
Developments in Biologicals
volume
112
pages
153 - 163
publisher
Karger
external identifiers
  • scopus:0041303558
ISSN
1424-6074
language
English
LU publication?
no
id
a15a99f9-ed0e-4184-a6e8-84067a491cde (old id 1127424)
date added to LUP
2008-06-09 13:41:28
date last changed
2018-05-29 12:01:45
@article{a15a99f9-ed0e-4184-a6e8-84067a491cde,
  abstract     = {The immunogenicity of biological therapeutic products is currently a high profile regulatory and biotechnology industry issue. The immune responses raised against biotechnology products range from the benign, to affecting product efficacy, to those that have serious deleterious clinical impact. The most widely used marker of immunogenicity is the detection and measurement of antibody responses induced in vivo to a product. This relies on assays that are sensitive and robust. In order to assess the parameters of an assay during its design, development and validation, it is extremely useful to have a reference standard to compare assay results. However, immune responses lead to polyclonal antibody preparations that can vary by affinity and avidity. This makes it extremely difficult to select a preparation that will behave similarly in different test systems and against different antibody samples. The case example of the WHO standardization of islet cell antibodies illustrates the difficu},
  author       = {Mire-Sluis, A and Gaines Das, R and Lernmark, Åke},
  issn         = {1424-6074},
  language     = {eng},
  pages        = {153--163},
  publisher    = {Karger},
  series       = {Developments in Biologicals},
  title        = {Standardization of antibody preparations for use in immunogenicity studies: a case study using the World Health Organization International Collaborative Study for Islet Cell Antibodies.},
  volume       = {112},
  year         = {2003},
}