Biodistribution at TATAA
Advancing PCR bioanalysis

Biodistribution of gene therapy products

At TATAA Biocenter, we collaborate closely with you to design tailored assays that precisely measure your gene therapy product or the associated messenger RNA in both target and non-target tissues of your choice. Our assays are validated according to regulatory requirements.

Biodistribution guided by FDA and EMA

Nonclinical biodistribution

Quantitative PCR (qPCR) and digital PCR (dPCR) are considered the standard assays for biodistribution studies. At TATAA Biocenter, we develop, optimize, and validate extraction and qPCR/dPCR assays for the biodistribution assessment of gene therapy products, including siRNA, viral vectors, genetically modified cells, and messenger RNA (mRNA). Our approach provides reliable, high-quality data that supports robust scientific conclusions.

Biodistribution FDA

ICH S12 guideline on nonclinical biodistribution

At TATAA Biocenter, we adhere to FDA and EMA guidelines, which state that validated extraction and assay designs should be used to quantify the in vivo distribution, persistence, and clearance of a gene therapy product, as well as the expressed mRNA if relevant. Each assay must provide a comprehensive description of the methodology, including detailed performance parameters such as sensitivity and reproducibility.

blood sample for olink target 48

Immunological considerations

Preexisting immunity can significantly affect biodistribution profiles, necessitating pre-immunity testing. An immune response after administration may lead to unreliable biodistribution data.
Using only microliters of plasma or blood samples, we use Olink Target 48 Cytokine panels to monitor the innate immune response activation through absolute quantification of key cytokines.

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PK/PD​ bioanalysis

General Biodistribution Page

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