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.
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.
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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Biodistribution assay design
Extraction
The extraction method must be evaluated for every tissue and target since the target’s length, modifications, and secondary structures can significantly impact extraction efficiency. For specific matrices, an extraction-free method may even be preferred.
Sample management, QC, and QA
Our regulated sample management processes include a Laboratory Information Management System (LIMS) for full traceability of samples and reagents, and a purpose-built laboratory to mitigate contamination risks and ensure the highest sensitivity possible. All data undergoes 100% QC, and QA according to regulatory requirements.
Assay development
We collaborate with you to design target-specific primers and probes, validating them for their context of use (COU). We run tests to ensure the PCR range meets requirements and achieves the lowest limit of detection (LOD) needed using qPCR or digital PCR, depending on the study. For short targets like siRNA, we use our Two-Tailed PCR.
Collaboration, reporting, and data transfer
Our principal investigators work closely with our sponsors, ensuring transparency in the process and project progression. Throughout the assay design, we keep sponsors informed of optimization steps, viewing ourselves as your extended workbench of experts. We customize the report to align with your downstream processes.
qPCR primer design for ATMPs This guide discusses strategies for designing qPCR assays, including primers and probes, for bioanalysis in cell and gene therapies. Download Information Our qPCR primer design and validation services Ask a question Schedule a meeting qPCR
About us
The power of our approach
Committed to quality, innovation, and fostering strong client relationships, we serve as your trusted partner to accelerate drug development. As a contract research organization, our mission is to push the boundaries of science and technology to generate accurate and reproducible data that shortens time-to-market.
Regulated laboratory environment
We are GLP accredited for qPCR, dPCR, and molecular biology, GCLP compliant, and ISO/IEC 17025 accredited. Our facility features a strict sample management process, a fully integrated LIMS system, backup for all vital systems, temperature and humidity control, and robust IT security.
Purpose-built PCR laboratory
Our purpose-built laboratory in Gothenburg, Sweden, is specifically designed for PCR. It has controlled air pressure, temporal separation, and biosafety cabinets to minimize contamination risk. This setup enables us to achieve the highest sensitivity and robustness required for validated assays. The lab is equipped with market-leading PCR and NGS instruments and advanced liquid handling systems.
Pioneers in assay development and validation
We are a team of 45 employees, with scientists at the forefront of assay development, optimization, and validation. Our team has co-authored key publications in the field, including Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development (AAPS J. 2024) and The MIQE Guidelines for qPCR and dPCR.
Flexible, client-centered solutions
We work closely with our clients to find tailored solutions, offering flexibility in sample types, test items, sample volume, and scalability. We prioritize transparency and proactive communication throughout each project, ensuring our clients are continuously updated on the progress.
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