ROME, Italy — June 22, 2026
As biologics, biosimilars and ATMPs grow more complex, immunogenicity is becoming an earlier decision point in development. Anti-drug antibodies can blur PK/PD data, interfere with assays, reduce therapeutic effect or complicate safety interpretation. For sponsors working across regions, EMA vs FDA expectations also influence how risk assessment, ADA detection and mitigation strategies are planned.
DI Markus Roucka, former VelaLabs/Tentamus, Austria, says the issue often appears before teams expect it. “ADA testing is not something you clean up at the end,” he said. “If antibodies change how a therapy behaves in the body, you need to know while there is still time to act.”
In his view, ATMPs deserve particular attention because cell and gene therapies may involve viral vectors, engineered cells and immune modulation that is part of the therapeutic effect itself. That can make adverse-effect assessment less straightforward. In early development, he notes, high drug levels may mask ADAs and lead to false negatives, surrogate positive controls may not reflect patient responses, and matrix interference from rheumatoid factors, heterophiles or co-medications can distort assay results.
The online live training Immunogenicity of Biologics, Biopharmaceuticals & ATMPs, taking place on 23 & 24 September 2026, covers ADA concepts, analytical terms, screening/confirmation/neutralization assays, preclinical study design, assay development and clinical immunogenicity pitfalls.
The programme brings together DI Markus Roucka on ADA concepts and assay considerations, Thorsten Meyer, Executive Consultant at Granzer Regulatory Consulting, Germany, on regulatory strategy and clinical development risks, and Marion Prior, Deputy Head Business Development at VelaLabs, Austria, on analytical development and bioanalytical methods.
Sessions also cover quality requirements, mitigation strategies, analytical tools, mAbs, ATMPs, biosimilars, case studies and future recommendations for risk minimization.
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