Bioanalytical CRO

Pioneering PCR innovation at scale

As the only GLP-accredited laboratory in Sweden for molecular biology, qPCR, and dPCR, we are your pioneering partner in solving complex bioanalysis challenges. Our customer-focused approach ensures that we work collaboratively with you to deliver innovative, high-quality assay development for ATMP bioanalysis. With our solutions-oriented and responsible team, we provide precision in every project.

Nucleic acid experts

Supporting drug development

At the forefront of bioanalysis, we specialize in quantifying gene therapy products and messenger RNA in various matrices for bioanalysis and biomarker expression. With 20 years of experience and a purpose-built laboratory, we design assays to detect low target numbers with the sensitivity required for biodistribution, shedding, and expression studies.

Why choose TATAA?

Molecular analysis is our expertise, our foundation, and our dedication. We are committed to providing tailored services to accelerate your program. Our Gothenburg facility is a purpose-built molecular laboratory with cutting-edge instrumentation, automated platforms, and an integrated LIMS system.

Your trusted data partner

With a team of PCR and NGS experts, we excel at conducting precise, efficient, and reliable assays while providing clients with a deeper understanding of the data. At every project step, we tailor our services to meet each client’s unique needs and provide end-to-end solutions from sample extraction to data transfer.

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.

Services

Solutions for complex biological challenges

We specialize in nucleic acid therapy drug development and bioanalysis, extracting and detecting your test item in biological samples with the necessary performance requirements, whether regulated or non-regulated. Additionally, we perform biomarker profiling on small non-coding RNAs, messenger RNA, genome, and protein.

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.

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.

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.

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

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.

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.

compliant bioanalysis

Accurate and reproducible data

A GLP accredited and GCLP compliant laboratory

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.

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

We are ahead of industry trends and always updated on the regulatory landscape and requirements for gene editing and nucleic acid-based therapies. Our purpose is to provide data that’s easily auditable.

Total project transparency

We maintain transparency and proactively communicate throughout the project, ensuring our clients always stay updated on the progress. Transparency forms the cornerstone of our proven client model.

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

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. Your goals are our deliverables.

contact US

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

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Bioanalytical CRO

Pioneering PCR innovation at scale

Nucleic acid experts