From discovery to approved treatment
Molecular analysis CRO
We specialize in PCR and NGS-based bioanalysis and biomarker profiling services for drug development, focusing on advanced therapies such as cell and gene therapies and RNA therapies.
Cell and gene therapy experts
Detection of viral and transgene RNA and DNA analytes
With decades of expertise in nucleic acid extraction, assay design, and optimization of PCR and NGS-based methods, we can extract, detect, and quantify trace amounts of nucleic acid targets within complex matrices. Our bioanalysis services analyze the distribution, persistence, and clearance of foreign nucleic acids and genetically modified cells with customized projects for each sponsor.
Molecular analysis for cell and gene therapies
We specialize in method development and assay validation for bioanalysis and quality assessment of cell and gene therapy products. We provide the necessary data for regulatory filings and gate decisions.
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 validation for regulatory filings and confident decision-making, ranging from fully validated assays to fit-for-purpose assays for various bioanalyses, including PK/PD, biodistribution, and viral shedding.
Clinical
With a state-of-the-art instrumentation fleet, automated platforms, and an integrated Laboratory Information Management System (LIMS), we conduct high-throughput analysis of clinical nucleic acid biomarkers for patient stratification, efficacy, and safety endpoint.
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
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.
Approval enables regulated analysis services for cell and gene therapies. This important milestone for TATAA Biocenter provides customers access to safety testing, accelerating the transition of promising therapies from laboratory research and preclinical testing to clinical applications. TATAA Biocenter announced
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development A new paper, with contributions from TATAA Biocenter, discussing the best practices for assay design, development, and validation testing in
A Guide to PCR in Drug Development In this unique guide from TATAA Biocenter, our experts discuss Polymerase Chain Reaction (PCR) and its role in drug discovery and pharmaceutical research in cell and gene therapies. To help you utilize PCR
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