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.

Stay in touch

Sign up for our newsletter

test

"*" indicates required fields

Name*

Biodistribution in gene therapy Biodistribution in cell and gene therapies and ATMPs requires optimized extraction protocols tailored for each test item. The extraction properties of short oligos like siRNA, miRNA, and ASO, as well as modified oligos, low-abundant targets, and

Biodistribution assays conducted in accordance with ICH S12 guidelines. Biodistribution aims to understand the distribution of therapeutic genetic material in various target and non-target tissues in cell and gene therapies. This data is crucial for correlating with mRNA expression data

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.

contact

Let's explore how we can support your drug development program.

PK/PD​ bioanalysis

One form for all pages, including link to mailchimp.

"*" indicates required fields

×

Olink

"*" indicates required fields

What platform of interest?*
Name*

General Enquiries

Please fill in the form below and we’ll get back to you ASAP.

"*" indicates required fields

Name*

Courses

Please fill in the form for any courses request

"*" indicates required fields

Name*

Sign up to our Newsletter

"*" indicates required fields

Name*

Bioanalytical Services

Please fill in the form below and one of our bioanalytical experts will get back to you ASAP.

"*" indicates required fields

What services are you interested in?*
This field is hidden when viewing the form

Products

Please fill in the form below for any products request

"*" indicates required fields