Mitigation Strategy for Eliminating NAb-arm-2 False Negative Response

Mitigation Strategy for Eliminating NAb-arm-2 False Negative Response

Bi- and tri-specific therapeutics have reshaped the field of immunotherapy by targeting multiple epitopes simultaneously. As these therapies become more complex, so too do the challenges in designing reliable neutralizing antibody (NAb) assays. In particular, interference between drug-target arms can mask the detection of NAbs, leading to inaccurate results. This whitepaper from Smithers Pharmaceutical Development Services Division explores a case where interference from one therapeutic arm obscured detection in another, and it presents a validated solution to address this issue.

What you will learn in this whitepaper:

  • How interference between drug arms can create false negative responses in NAb assays.
  • The limitations of the original assay method and the specific challenges observed when both NAb-arm-1 and NAb-arm-2 are present.
  • The rationale for modifying the assay design, including the addition of Drug-arm-1 Target to the neutralization buffer.
  • Experimental data demonstrating the impact of interference and the effectiveness of the modified method.
  • Recommendations for evaluating mixed NAb samples to more accurately reflect study conditions.
  • Broader implications for assay design in bi- and tri-specific therapeutics, and how this approach can be applied to minimize unwanted interference.

Download the Scientific Poster:

Smithers-Mitigation-Strategy-for-Eliminating-NAb-arm-2-False-Negative-Response
Smithers-Mitigation-Strategy-for-Eliminating-NAb-arm-2-False-Negative-Response
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