Sapio Sciences expands immunogenicity testing capabilities in laboratory informatics platform
Laboratory software provider Sapio Sciences has announced new immunogenicity bioanalysis features within its laboratory informatics platform, specifically enhancing its Laboratory Information Management System (LIMS) and Electronic Laboratory Notebook (ELN) solutions.
Streamlined approach to tiered testing
The platform now incorporates comprehensive support for the standard tiered-testing methodology required for immunogenicity studies, encompassing screening assays, confirmatory testing, titre determination and neutralising antibody (NAb) analysis. These enhancements are designed to align with current FDA and EMA regulatory guidelines for anti-drug antibody (ADA) detection and characterisation.
Integrated workflow management
Notable features include configurable immunogenicity workflows that can be modified without coding expertise, addressing the needs of laboratories conducting complex bioanalytical studies. The system provides real-time instrument integration and data synchronisation, offering scientists a consolidated environment for monitoring assay progression and managing sample dilutions.
The platform’s data management capabilities extend from initial sample acquisition through to final reporting, incorporating tools for assay configuration, quality control measures and data visualisation. Particular attention has been paid to regulatory compliance, with built-in validation protocols for monitoring cut points, sensitivity, selectivity and stability parameters.
Commenting on the development, Sapio Sciences’ Founder and CEO Kevin Cramer said: “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.”
He added: “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.”
The platform serves various laboratory environments, including biopharmaceutical companies, contract research organisations (CROs), contract development and manufacturing organisations (CDMOs), and clinical diagnostic facilities. Its applications span NGS genomic sequencing, bioanalysis, bioprocessing, chemistry, stability testing, histopathology and in vivo studies.
For more information, visit: www.sapiosciences.com
Digital issue: Please click here for more information
Kevin Cramer, Sapio Sciences’ Founder and CEO
