Bioanalytical Services

We will assess your genetic medicine throughout the preclinical and clinical stages.

Bioanalysis that Guides Advanced Therapeutic Development

Understanding the biological effects of a drug product is essential to developing safe and effective advanced therapies. Efficient evaluation of immunogenicity, biodistribution, viral shedding, and biomarkers supports dose optimization, target validation, and early identification of potential toxicities.

Engage Our Scientists and Industry Leaders

Our immunology core serves as a global reference lab for evaluating humoral and cellular immune responses before and after advanced therapy administration. We offer a broad range of sensitive, validated assays for biodistribution and biomarker analysis, supporting the comprehensive characterization of genetic medicines. Our expert team can assist in selecting or developing the optimal biomarker(s), with standard, custom, and GLP-compliant options available to meet your program’s specific needs.

Served >75 companies and institutions

Performed >25,000 preclinical and >2,400 clinical assays over the last 5 years

Supported more than 40 clinical trials

Immunogenicity

Immune responses, particularly neutralizing antibodies to AAVs, can impact therapeutic efficacy and safety. Our team provides expert support to assess immunogenicity at every stage of development, from preclinical research to clinical trials.

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Biodistribution and
Viral Shedding

Our biodistribution and viral shedding studies feature quantitative gene expression analysis by qPCR across a wide range of tissue and fluid matrices. With validated assays designed to support GLP-compliant programs, we deliver precise, reliable data to meet regulatory expectations and guide therapeutic development.

Biomarkers and Protein Expression

Our biomarker and protein expression services utilize advanced platforms including Mass Spectrometry, ELISA, and Meso Scale Discovery (MSD) to deliver sensitive, quantitative analysis. These technologies support robust evaluation of pharmacodynamic markers, mechanism of action, and therapeutic response across preclinical and clinical studies.