PHARMA CONTRACT RESEARCH ORGANIZATION
Pioneering PCR innovation at scale
We apply the latest technologies, proprietary methods, and more than 20 years of expertise to deliver PCR and NGS-based method development, validation, and high-throughput analysis to biopharmaceutical companies globally.
Nucleic acid experts
Supporting drug development
We specialize in accurately quantifying RNA and DNA targets within complex biological samples. Our expertise is in detecting therapeutic nucleic acid products for bioanalysis, biomarker quantification, and other advanced applications relevant to cell and gene therapy, advanced therapy, and RNA therapy development programs.
Why choose TATAA?
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.
Molecular analyses in drug development
Support at every phase for well-informed decisions
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 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.
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.
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
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
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.
contact US
Let's explore how we can support your drug development program.
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