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Development and Validation of an Efficient and Highly Sensitive Enzyme-Linked Immunosorbent Assay for Alemtuzumab Quantification in Human Serum and Plasma. | LitMetric

AI Article Synopsis

  • Alemtuzumab is a monoclonal antibody used mainly to prevent immune reactions in patients undergoing stem cell transplants by targeting CD52 on lymphocytes.
  • Researchers developed a highly sensitive enzyme-linked immunosorbent assay to measure alemtuzumab levels in human serum, overcoming limitations of existing methods.
  • The assay showed a strong performance with accurate quantification capabilities, allowing for better understanding of patient exposure and response to alemtuzumab treatment to improve treatment strategies.

Article Abstract

Background: Alemtuzumab is a humanized monoclonal antibody that targets the CD52 glycoprotein expressed on most lymphocytes, subsequently inducing complement-mediated and antibody-mediated cytotoxicity. Owing to its ability to induce profound immune depletion, alemtuzumab is frequently used in patients before allogeneic hematopoietic stem cell transplantation to prevent graft rejection and acute graft-versus-host disease. In this clinical context, a stable immunoassay with high sensitivity and specificity to determine alemtuzumab levels is essential for performing pharmacokinetic and pharmacodynamic analyses; however, the available methods have several limitations. Here, we report the successful development and validation of an efficient and highly sensitive enzyme-linked immunosorbent assay technique based on commercially available reagents to quantify alemtuzumab in human serum or plasma.

Methods: This enzyme-linked immunosorbent assay technique was developed and validated in accordance with the European Medicines Agency guidelines on bioanalytical method validation.

Results: The assay sensitivity (lower limit of quantification) is 0.5 ng·mL -1 , and the dynamic range is 0.78-25 ng·mL -1 . To accommodate quantification of peak concentration and concentrations below the lympholytic level (<0.1 mcg·mL -1 ), patients' serum samples were prediluted 20-400 times according to the expected alemtuzumab concentration. The overall within-run accuracy was between 96% and 105%, whereas overall within-run precision (coefficient of variation) was between 3% and 9%. The between-run assessment provided an overall accuracy between 86% and 95% and an overall coefficient of variation between 5% and 14%.

Conclusions: The developed assay provides accurate insight into alemtuzumab exposure and its effects on the clinical response to treatment, which is key to optimizing treatment strategies.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9819214PMC
http://dx.doi.org/10.1097/FTD.0000000000001037DOI Listing

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