Immunogenicity assessment

Biological therapeutics revolutionized the treatment of several cancer types, autoimmune disorders and inborn error metabolic diseases. They provide better options for clinicians and improve the quality of life for the patients. However, biologic’s immunogenicity has been considered a major clinical issue due to the development of anti-drug antibodies (ADA), which may block or suppress the drug’s pharmacological effect, leading to loss of clinical response or even raising safety issues.

Drug immunogenicity assessment and PK assays to support clinical development of biotherapeutic medicines:

• Assay development and validation to assess drug immunogenicity
• Anti-drug antibodies (ADA) screening, confirmation and titer
• Detection of neutralizing ADA (Nab)
• Drug tolerant assays to detect ADA immune complexes
• Next generation tools to measure binding affinity and ADA serum concentration in clinical samples
• Customized PK assays to support therapeutic drug management in patients receiving antibody therapeutics
• Characterization of ADA response in long-term enzyme replacement therapies in patients with lysosomal storage disorders