Sapio Immunogenicity Testing
Accurate detection, tracking, and management of immune responses
Efficiently Detect Immune Response To Biologics.
When biologic drugs are introduced into a patient’s body, there’s a risk of an immune response where the patient generates anti-drug antibodies (ADA). These antibodies may interfere with the drug’s effectiveness by neutralizing its impact, posing a significant challenge in drug efficacy and patient safety. Detecting and managing this immune response is essential for ensuring the safety and success of biologics in clinical treatments.
Sapio Sciences offers an advanced immunogenicity bioanalysis platform that ensures the accurate detection, tracking, and management of immune responses in patients treated with biologics. Sapio’s solution integrates seamlessly with laboratory systems, allowing for efficient ADA and neutralizing antibody (NAb) testing workflows and ensuring compliance with regulatory requirements.
Sapio simplifies immune response management.
Comprehensive ADA/NAb Testing
The Sapio platform supports the complete immunogenicity testing workflow, including screening, confirmatory, titer, and NAb assays, ensuring the streamlined handling of all ADA and NAb detection aspects.
Seamless Data Management
With Sapio’s electronic laboratory notebook (ELN) integration, all results—from ADA screening to NAb testing—are efficiently captured, stored, and reported in compliance with FDA/EMA guidelines.
Automated Cut Point Calculations
Sapio’s platform enables automatic and customizable cut-point analysis, ensuring consistent and precise interpretation of assay results and reducing manual data handling errors.
Pre-built Instrument Integrations & Analytics
Automating instrument data integration with built-in analytics allows for precise processing of assay results, stability assessments, and selectivity measurements, generating detailed and customizable reports.
Discover how Sapio Immunogenicity and Bioanalysis support your lab.
Flexible and Comprehensive.
Sapio Immunogenicity
Immunogenicity testing is a critical component of biological drug development and safety monitoring. Sapio Sciences provides a fully integrated solution that supports the entire tiered testing strategy, from ADA screening to NAb assays. Sapio’s platform ensures that all steps—screening, confirmatory, and titer assays—are performed precisely and accurately, minimizing risks and ensuring compliance with regulatory standards.
Sapio’s ELN system accommodates all facets of immunogenicity assay development, such as reagent management, assay validation, and detailed reporting of ADA and NAb test results. Sapio’s solution also supports critical calculations, including cut points, sensitivity, and specificity measurements, ensuring a robust immunogenicity testing process.
Sapio Immunogenicity Key Features:
ADA and NAb Assay Support:
Manage ADA screening, confirmatory, titer, and NAb assays in a single platform.
Cut Point and Sensitivity Calculations:
Automate complex calculations to ensure assay accuracy and reliability.
FDA/EMA Compliance:
The Sapio platform ensures all assay results meet regulatory standards, including sensitivity, selectivity, specificity, and precision.
Reagent and Metadata Management:
Track all reagents used in testing and link results to patient data, study time points, and treatment details.
Customizable Reporting:
Generate comprehensive reports that accommodate all assay parameters, from titer levels to drug response curves.
Automated Data Analysis:
Incorporates advanced tools like JMP to evaluate sample data and ensure precise analysis of ADA and NAb results.
GMP lab solution resources
Brochure
Bioanalysis Application Sheet
Webinar
Mastering Bioanalytical Workflows
Case Study
ImmuneBridge Case Study
Let us show how Sapio can support your organization’s quality and compliance requirements.
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