▾ G11 Media Network: | ChannelCity | ImpresaCity | SecurityOpenLab | Italian Channel Awards | Italian Project Awards | Italian Security Awards | ...
InnovationOpenLab

Sapio Sciences Enhances Bioanalysis LIMS and ELN with Advanced Immunogenicity Capabilities

Sapio Sciences, the science-aware™ lab informatics platform, today announced the addition of new immunogenicity bioanalysis features to its industry-leading lab informatics platform. These new capab...

Business Wire

Enhancements support ADA and NAb testing workflows, boosting lab efficiency and regulatory compliance for drug development

BALTIMORE: Sapio Sciences, the science-aware™ lab informatics platform, today announced 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/

About Sapio Sciences

Sapio Sciences' mission is to improve lives by accelerating discovery, and because science is complex, Sapio makes technology simple. Sapio is a global business offering an all-in-one science-aware™ lab informatics platform combining cloud-based LIMS, ELN, and Jarvis data solutions.

Sapio serves some of the largest global and specialist brands, including biopharma, CRO/CDMOs and clinical diagnostic labs across NGS genomic sequencing, bioanalysis, bioprocessing, chemistry, stability, histopathology, and in vivo studies.

Customers love Sapio's platform because it is robust, scalable, and with no-code configuration, can quickly adapt to meet unique needs.

For more information, visit www.sapiosciences.com and follow us on LinkedIn.

Fonte: Business Wire

If you liked this article and want to stay up to date with news from InnovationOpenLab.com subscribe to ours Free newsletter.

Related news

Last News

RSA at Cybertech Europe 2024

Alaa Abdul Nabi, Vice President, Sales International at RSA presents the innovations the vendor brings to Cybertech as part of a passwordless vision for…

Italian Security Awards 2024: G11 Media honours the best of Italian cybersecurity

G11 Media's SecurityOpenLab magazine rewards excellence in cybersecurity: the best vendors based on user votes

How Austria is making its AI ecosystem grow

Always keeping an European perspective, Austria has developed a thriving AI ecosystem that now can attract talents and companies from other countries

Sparkle and Telsy test Quantum Key Distribution in practice

Successfully completing a Proof of Concept implementation in Athens, the two Italian companies prove that QKD can be easily implemented also in pre-existing…

Most read

AI Strengthening Cybersecurity Software, ISG Says

$III #AI--Growing and evolving security threats make it increasingly important for enterprises to deploy advanced cybersecurity software and to understand…

Mitsubishi Electric’s ME Innovation Fund Invests in AI-assisted PLM Systems…

Mitsubishi Electric Corporation (TOKYO: 6503) announced today that its ME Innovation Fund has invested in Things, Inc., a Japan-based startup that develops…

Taiwan Prepaid Card and Digital Wallet Market Databook 2025: Prepaid Card…

The "Taiwan Prepaid Card and Digital Wallet Market Intelligence and Future Growth Dynamics Databook - Q2 2025 Update" report has been added to ResearchAndMarkets.com's…

CyberCube Flags Sectors at Highest Risk for Scattered Spider Attacks

CyberCube, the global leader in cyber risk analytics, has identified Manufacturing, Education, IT, and Retail as the sectors most at risk of attacks from…

Newsletter signup

Join our mailing list to get weekly updates delivered to your inbox.

Sign me up!