Immunogenicity Evaluation for Therapeutic Drugs

Immunogenicity risk assessment is a vital step in the development of therapeutic drug products. Immunogenicity assays are essential as they help us assess the anti-drug antibody response from a patient’s immune system, providing valuable insights into the drug’s safety and efficacy.

KCAS Bio specializes in immunogenicity evaluation across both non-GLP and GLP settings, offering customized assays for all phases of drug development. Our skilled ligand binding assay team of 60+ professionals has extensive expertise in developing a wide range of immunogenicity assays, from ADAs to cell-based NAbs. We are equipped to tackle challenges such as high background or limited drug tolerance, ensuring success from experimental design to method development, validation, and bioanalysis.

KCAS Bio has experience in assessing immunogenicity in a wide range of Biologics:

• Monoclonal Antibodies
• Antibody Fragments
• Antibody Drug Conjugates (ADCs)
• Fusion Proteins
• Gene Therapies
• Oligonucleotides

KCAS Bio is your trusted partner in navigating the complexities of immunogenicity risk assessment and assay development. With a broad range of expertise, we ensure that your therapeutic products meet the highest standards for safety and efficacy.  Our experienced team is committed to providing customized solutions at every stage of drug development, helping you overcome challenges and achieve successful outcomes in immunogenicity evaluation.

Contact KCAS Bio today to learn how our expert immunogenicity services can support your drug development process!