- Enhancements support ADA and NAb testing workflows, boosting lab efficiency and regulatory compliance for drug development
Baltimore, MD – Sapio Sciences, the science-aware™ lab informatics platform, announces the addition of new immunogenicity bioanalysis features to its industry-leading lab informatics platform. These new capabilities in the Sapio LIMS (Laboratory Information Management System) and Sapio ELN (Electronic Lab Notebook) solutions streamline testing workflows for detecting anti-drug antibodies (ADA) and neutralizing antibodies (NAb).
Immunogenicity bioanalysis follows an industry-standard tiered-testing approach, including assay screening (all samples), confirmatory testing (positive samples), titer (sample dilution), and, finally, a NAb assay to evaluate drug efficacy. This bioanalysis workflow, along with the results, must be closely managed to ensure compliance with the FDA/EMA guidelines, guaranteeing error-free detection of ADA/NAb.
Key features of the Sapio immunogenicity capabilities in Sapio ELN and LIMS include:
- Tiered Testing Support: Sapio’s platform now supports the full range of immunogenicity testing, from ADA and NAb assays to screening, confirmatory, and titer testing. Aligning with the industry-standard tiered testing approach ensures laboratories can validate the presence and impact of antibodies.
- Configurable Workflows: The highly configurable Sapio Platform allows laboratories to easily tailor and adjust immunogenicity bioanalysis workflows, from assay development to sample analysis, without the need for custom coding.
- Seamless Integration: Sapio’s unified platform offers comprehensive integration with lab instruments, ensuring real-time data collection and synchronization, giving scientists a unified environment in which to track assay progress, manage sample dilution, and generate reports.
- Comprehensive Data Management: The platform provides end-to-end traceability, from sample collection to reporting results, with built-in tools for assay setup, quality control, and data visualization.
- Data Validation and Compliance: The Sapio LIMS and ELN ensure adherence to the FDA and EMA-guided IGX assay validation approach, providing for monitoring and reporting on cut points, sensitivity, selectivity, and stability.
Kevin Cramer, Founder and CEO of Sapio Sciences, commented: “The integration of immunogenicity bioanalysis into our LIMS and ELN will enable scientists to conduct highly regulated and complex bioanalytical studies with greater confidence, efficiency, and accuracy.” Kevin continued: “The rapid advances in bioanalysis necessitate continual development of the informatic tools that scientists use to test and prove the efficacy of new drugs. The new features of our bioanalysis ELN and LIMS to manage immunogenicity testing are just the latest of many advanced capabilities added to our platform to accelerate drug discovery.”
For more information, visit https://www.sapiosciences.com/solutions/immunogenicity/
