Proven intelligence in bioanalysis accelerates next-generation therapies. Our laboratories provide comprehensive support for programs across all modalities, from advanced therapeutics including AAV, lentivirus, CRISPR, cell therapies, and RNA/LNP systems to complex biologics like monoclonal antibodies and recombinant proteins. We deliver the precise data required to characterize biological activity and guide programs from preclinical evaluation through clinical trials.

Understanding the pharmacokinetics, pharmacodynamics, and immunogenicity of a therapeutic candidate is fundamental to minimizing clinical risk. Our approach focuses on generating decision-making data that informs program optimization, confirms target engagement, and provides early identification of potential off-target effects or unwanted immune responses. This analytical rigor is built on a foundation of deep experience supporting sponsors from discovery to regulatory submission.

Core Bioanalytical Capabilities

A tailored, science-driven bioanalytical strategy is developed for each asset. We do not apply a standard template; instead, we design a testing program specific to the modality and target indication.

• Immunogenicity: Our immunology core provides expert assessment of pre-existing immunity and treatment-emergent immunogenicity for a variety of advanced therapeutics. For AAV programs specifically, we function as a dedicated reference laboratory, offering highly specialized evaluation of humoral and cellular immune responses, including robust neutralizing antibody (NAb) assays.
• Biodistribution and Viral Shedding: We utilize quantitative PCR (qPCR), digital droplet PCR (ddPCR) and other molecular methods to determine vector distribution, expression, persistence, and clearance across a wide range of tissue and fluid matrices. These assays are designed to support GLP-compliant programs and meet regulatory expectations.
• Biomarkers and Protein Expression: Using advanced platforms including Mass Spectrometry, ELISA, and Meso Scale Discovery (MSD), we deliver sensitive, quantitative analysis of pharmacodynamic markers. This supports robust evaluation of the mechanism of action and therapeutic response.