Biologic and Large Molecule Characterization
Immunogenicity
Addressing complex immunogenicity challenges — including multi-domain and PEGylated proteins, complement activation, and immunogenicity assessment for CAR-T and gene therapy modalities — with scientifically rigorous, fit-for-purpose assay strategies.
Large Molecule PK
Full-lifecycle development, validation, and implementation of ELISA and MSD-based assays for biologic quantification, complemented by flow cytometry and ddPCR platforms for cell and gene therapy pharmacokinetic assessments.
NAb & TAb Assays
Deploying a broad range of methodological approaches — including ELISA and MesoScale Discovery platforms — for the development and validation of neutralizing antibody and total antibody assays, with the capability to advance these into companion diagnostic formats.
Innovative Bioanalysis Technologies
We combine established technologies, proprietary platforms, and validated biomarker assays to generate reliable, high-quality data across a wide range of biological samples, including nucleic acids, proteins, cells, and tissues.
Meso Scale Discovery (MSD)
Sensitive and reproducible quantification of analytes in complex biological matrices for immunogenicity and pharmacokinetic assessments, including ADA, NAb, TAb, and PK assays.
ELISA
Delivering gold-standard antibody-based bioanalytical services with specialized expertise in the development, optimization, and validation of immunogenicity assays for biologic and therapeutic programs.
Olink® Proteomics
High-throughput multiplex protein biomarker analysis with exceptional sensitivity and specificity, requiring only minimal clinical sample volumes.
Bioanalytical Scientific and Technical Expertise
CNC Path Lab provides comprehensive bioanalytical expertise to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity profiles of biologics and advanced therapeutics. Our capabilities support every stage of drug development, from IND-enabling preclinical studies through all phases of clinical trials.
Leveraging advanced analytical platforms and scientific expertise, we design and deliver fit-for-purpose bioanalytical assays tailored to each program's development stage, therapeutic modality, and risk profile. Our robust quality systems ensure compliance with global regulatory standards while generating reliable, high-quality data.
We also support the development and validation of specialized assays, including neutralizing antibody (NAb) assays for AAV-based gene therapies and companion diagnostic programs. Our bioanalytical services are designed to support a broad range of therapeutic areas, including Oncology, Rare Diseases, Gastroenterology, Immunology, and other precision medicine applications.
Life science innovators
come to CNC Path Lab
Ready to accelerate your clinical program? Our experts are here to help you design and execute the perfect laboratory strategy. Are you ready?