Advancing PCR bioanalysis
Molecular analysis CRO
Our mission is to provide you with data that accurately reflects the performance of your gene therapy product or construct, enabling impactful, informed decisions.
Vector DNA, siRNA, messenger RNA
Detection of viral and transgene RNA and DNA analytes
With over 20 years of experience, we address the most complex challenges in ATMP bioanalysis with precision and expertise. We prioritize quality, innovation, and building strong client relationships to tailor assays to your needs and regulatory requirements.
Molecular analysis for cell and gene therapies
We optimize extractions from your preferred tissues or biofluids and select the appropriate analysis technology based on the context of use (COU). Our team designs, optimizes, qualifies, and validates primers and probes for various applications, like biodistribution, shedding, and gene expression assays.
Clinical biomarker profiling
We employ next-generation sequencing to discover nucleic acid biomarkers and utilize various PCR-based technologies for targeted, high-throughput quantification of clinical biomarkers. As an Olink-approved service provider, we offer highly multiplexed, quantitative proteomics panels.
Molecular analyses in drug development
Support at every phase for well-informed decisions
We accelerate time-to-market with rapid and reliable data, enabling informed stage-gate decisions and preparing submission-ready reports. We excel at identifying and monitoring nucleic acid biomarkers essential for understanding target engagement, efficacy, potency, and safety of cell, gene, and RNA therapies.
Discovery
In early discovery, we identify valuable biomarkers for candidate selection, lead optimization, and patient stratification. In addition, we run quantitative analyses to provide the necessary data for vector evaluation and optimization, including tissue specificity and potency for lead candidate selection.
Preclinical
We offer a spectrum of assay validations for regulatory filings and confident decision-making, ranging from fully validated assays to fit-for-purpose assays for various bioanalyses, including biodistribution and messenger RNA detection.
Clinical
With regulated sample management processes, a state-of-the-art instrumentation fleet, automated platforms, and an integrated Laboratory Information Management System (LIMS), we conduct high-throughput analysis of tailored, GCLP-compliant assays for clinical nucleic acid biomarkers.
Discovery
In early discovery, we identify valuable biomarkers for candidate selection, lead optimization, and patient stratification. In addition, we run quantitative analyses to provide the necessary data for vector evaluation and optimization, including tissue specificity and potency for lead candidate selection.
Preclinical
We offer a spectrum of assay validation for regulatory filings and confident decision-making, ranging from fully validated assays to fit-for-purpose assays for covering various bioanalyses, including PK/PD, biodistribution, and viral shedding.
Clinical
We use the highest quality reagents, adhere to dedicated controls, standardize and harmonize all processes per technical requirements like the MIQE guidelines. We deliver rapid, robust and reproducible results that are submission-ready.
applications
Solutions for complex biological challenges
We offer a comprehensive range of tailored services for drug development programs. With over two decades of expertise in nucleic acid analysis and sample preparation, we excel in sample extraction and quality assessment, method development and validation, and analyzing biomarkers using leading, well-matched technologies.
compliant bioanalysis
Accurate and reproducible data
TATAA Biocenter is accredited by the Swedish Board of Accreditation and Conformity Assessment (SWEDAC) for complying with Good Laboratory Practice (GLP) standards. We also adhere to Good Clinical Laboratory Practice (GCLP) guidelines, which are international quality standards governing the analysis of samples from clinical trials using GLP.
GLP and GCLP validation is mandatory in preclinical and clinical assays to demonstrate accuracy, reliability, and consistency. These standards cover every aspect of study planning, execution, monitoring, documentation, archiving, and reporting. This rigorous process assures both the sponsors, when submitting data for new drug approvals, and the regulatory authorities, when reviewing the data, that it is generated in a regulated manner.
technologies
We operate with the latest technologies
TATAA Biocenter comprises highly skilled scientists with extensive expertise in method development, optimization, validation, and optimization of molecular analysis. We leverage market-leading instrumentation and automation platforms, offering expert guidance to choose the most suitable technology for your program.
PCR
We use highly sensitive and highly precise quantitative PCR (qPCR) and digital PCR (dPCR) technologies to detect one or multiple DNA/RNA targets in complex samples.
NGS
We use NGS, a powerful tool to sequence entire exomes, genomes, or transcriptomes, and our scientists and bioinformaticians provide comprehensive sequencing data.
Quantitative proteomics
We are a designated Olink service provider with the latest technologies for running quantitative proteomics using Olink’s panels for biomarker discovery, validation, and screening.
method validation
Accelerate drug development with validated assays
Validated bioanalysis is essential throughout the entire drug development process.
Conducting fit-for-purpose validations in the initial stages of discovery is key. These validations offer valuable insights of expected assay performance before undertaking more comprehensive method validation processes. A validated PCR assay is essential to ensure the accuracy and reliability of results and ensures that the assay meets the client’s needs, study requirements, and assay criteria under defined operating conditions. Our assay validations ensure dependable data for making stage-gate decisions and preparing regulatory filings.
A validated assay is a valuable asset.
why work with tataa?
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, we are committed to generating accurate and reproducible data that shortens time-to-market.
Experienced scientists
Total project transparency
Have confidence in your data
We use the highest quality reagents, adhere to dedicated controls, and standardize all processes per technical requirements like the MIQE guidelines. We deliver rapid, robust, and reproducible results that are submission ready.
Flexible and scalable
Your goals are our deliverables. Every project is customized to meet our client’s specific needs. We manage projects of all sizes and all stages, including any or all phases from sample extraction to analysis and data transfer.
Primer dimer test Primer-dimers can bias qPCR results, so a test for primer-dimers should be performed during assay development to ensure that only the target sequence is amplified and quantified. The effect of primer dimers Checking for primer dimers is
TCR sequencing TCR sequencing on DNA or RNA is used to understand anti-tumor immune responses and to track responses to infections, vaccinations, and immunotherapies. Our TCR sequencing services Ask a question What is a T-cell receptors (TCRs)? T-cell receptors (TCRs)
Pharmacokinetics (PK) in gene therapies Pharmacokinetics for genes introduced by gene therapies is more challenging than those of finished small molecules. Our custom assays for biodistribution, pharmacokinetics (PK), and shedding. Ask a question Pharmacokinetics (PK) in gene therapies Pharmacokinetics for
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