At BioLegacy, our bioanalytical laboratory translates your biological samples into definitive, quantitative data for confident decision-making. Our multi-platform approach accurately measures drug concentrations, assesses immunogenicity, and quantifies key biomarkers. Leveraging a diverse and integrated suite of advanced technologies – including high-sensitivity Meso Scale Discovery and ELISA for protein analysis, multi-color flow cytometry for cellular characterization, digital and real-time PCR for gene expression, and PK for gene and cell therapies – we deliver a robust, data package that provides deep mechanistic insight and fully supports your program’s regulatory submissions.
- Multi-Platform Ligand Binding Assays (LBAs): n various platforms, including ELISA and electrochemiluminescence (MSD), for PK, ADA, and biomarker analysis.
- Advanced Cellular Analysis: via multi-color flow cytometry.
- Gene Expression Analysis: and precise nucleic acid quantification using real-time (qPCR) and digital PCR (dPCR).
- GLP-Compliant Bioanalysis: Dedicated, GLP-compliant laboratory and Quality Assurance unit
- Support for a Broad Range of Modalities: Small molecules, large molecules, ADCs, targeted protein degraders (TPDs), cell and gene therapies, and others.
- Full Method Lifecycle Support: from de novo method development and phase-appropriate validation to GLP testing for IND-enabling studies.
- Integrated PK/PD & TK Analysis: Rapid sample turnaround and expert interpretation.
- Immunogenicity & Anti-Drug Antibody (ADA) Testing: Screening, confirmatory, and neutralizing antibody assays.
- Comprehensive Biomarker Services: Discovery, validation, and quantitative analysis of soluble and cell-based pharmacodynamic and safety biomarkers.
