Immunoassay Bioanalysis Service
Immunogenicity bioanalysis solutions for pre-clinical and clinical assessments.
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Immune responses to therapeutic products have the potential to affect Pharmacokinetics (PK), Pharmacodynamics (PD), safety and efficacy. Assessment of a biotherapeutics' ability to produce an immune response requires the development of customized immunoassays following a tiered approach. With a specialized team of scientists and regulatory project managers we have a wealth of experience in developing and validating sensitive, specific, selective, and drug/target tolerant ADA and NAbs assays to support non-clinical and clinical immunogenicity up to Phase IV post-marketing surveillance. All validation is performed to GCP or GLP standards in line with current regulations (FDA and/or EMA).
Challenges of developing an ADA assay for bispecific antibody therapeutics and ADA characterization
Bispecifics are biopharmaceutical products that bind to two different targets. In this application note, LGC describes the challenges of building anti-drug antibody (ADA) assays, and how to overcome these challenges. Download to explore how LGCs tiered approach provides validated assays that will support sample analysis throughout the method lifecycle.
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