Technical Bulletin: Successful Strategies to
Measure Anti Drug Antibodies.
The problem of drug induced immunogenicity has been a recognised phenomenon for
a number of years.
Anti-Drug Antibody (ADA) responses can lead to allergic reactions,
reduction or...
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Technical Bulletin: Successful Strategies to
Measure Anti Drug Antibodies.
The problem of drug induced immunogenicity has been a recognised phenomenon for
a number of years.
Anti-Drug Antibody (ADA) responses can lead to allergic reactions,
reduction or neutralisation of drug activity and potential cross reactivity.
Furthermore, in
preclinical studies, ADA can affect drug exposure, in turn affecting the interpretation of the
toxicity, pharmacokinetic and pharmacodynamic data.
The problems are difficult to predict
as immunogenicity is dependent on a number of known and unknown factors.
However, it is
now clear that as part of a successful clinical trials programme for market authorisation, an
assessment of the induction of an immune response by the drug is required.
The European
regulators have issued a document EMEA/CHMP/BMWP/14327/2006 which came into
effect in April 2008 to give guidance on the methodologies expected to be applied to new
biotechnology products.
One of the firs
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