Overcoming Bioanalytical Challenges in Anti-Drug Antibody Detection for ADCs

Antibody-drug conjugates (ADCs) and other next-generation drug modalities are unlocking new treatment possibilities. However, their unique designs can also create unexpected challenges for bioanalytical teams.

In this webinar, attendees will hear the story of a real-world ADC case study: a humanized single-chain antibody linked to a bacterial toxin protein. The team selected a bridging anti-drug antibody (ADA) assay based on the MSD platform, with the ADC biotinylated and conjugated to Sulfo-TAG, and introduced an acid dissociation step to improve drug tolerance.

Then came a surprising discovery: about 90% of naïve donor samples contained widely varying levels of pre-existing antibodies. A few low-signal samples were used to create a negative control pool, and the initial method design included screening, confirmatory, domain specificity and titer tiers.

Click below to learn how the team turned these challenges into a validated strategy for accurate ADA detection in complex clinical samples.

With this approach, the validated method was applied to Phase III study samples. As expected, most baseline samples were positive for pre-existing antibodies, particularly against the toxin domain. Despite this, the assay was able to identify treatment-boosted ADA and determine their domain specificity.

Register for this webinar to learn how to adapt ADA assay design to the unique bioanalytical challenges of ADCs. Topics will include practical strategies for dealing with high pre-existing antibody rates and lessons learned from real clinical sample analysis.

Speaker

Martin Roberge, PhD, Director, Development & Innovation, Bioanalytical Center of Excellence, Cerba Research

Martin Roberge has over 26 years of experience in the life science industry. Throughout his career in biotech and contract research organizations, Martin developed a thorough expertise in protein engineering, bioanalysis and drug development. At Cerba Research, Martin provides leadership and scientific expertise for method development and GLP/GCLP validation projects for large molecule drug products in support of preclinical and clinical studies. Methods include immunogenicity assays (ADA, NAb), PK assays, biomarkers, qPCR and others.

He earned his PhD in Biology from the University of Sherbrooke in Québec, Canada. His experience includes working at a start-up CRO in Montréal, a Scientist II position at Genencor International Inc. and completing a postdoctoral fellowship at Genentech Inc. in the Protein Engineering department.

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