Pioneers in PCR
Trusted provider of bioanalysis and biomarker analysis
We specialize in molecular analysis for cell and gene therapies, precision medicines, and other advanced therapies.
applications
Support at every phase for well-informed decisions
Our molecular analyses support every phase of drug development, from early discovery through biomarker validation to large clinical cohort studies for efficacy and safety. We ensure precise, actionable insights at each stage, enabling informed decisions throughout the development.
Biomarker discovery and validation
Our biomarker discovery and validation services are designed to help you identify and validate biomarkers that predict drug response, efficacy, and safety. We offer comprehensive analysis support, from initial discovery using NGS and qPCR to multiplex protein biomarker validation.
Immunoprofiling and immune response monitoring
We provide advanced immunoprofiling and immune response monitoring services to support the development of immunotherapies, cell and gene therapies, vaccines, and other biologics. Utilizing TCR/BCR sequencing, qPCR/dPCR, NGS, and Olink proteomics, we offer in-depth insights into the immune system’s response.
Cell and gene bioanalysis
We develop and validate highly sensitive assays from complex samples and unique test items through to final data for biodistribution, shedding, PK/PD, and transgene expression. Depending on regulatory requirements, the analysis is performed as fit-for-purpose, GLP, or GCLP.
Small non-coding RNAs
We use Two-tailed PCR technology to analyze short targets such as miRNA and siRNA. This technology enables high-throughput, validated qPCR/dPCR analyses for bioanalysis or biomarker purposes of these short targets.
Gene expression analysis
We offer comprehensive gene expression analysis services from early discovery through preclinical and clinical trials. We develop and validate assays for qPCR, dPCR, and Next-Generation Sequencing (NGS) to deliver precise, reliable, and regulatory-compliant gene expression data.
Genomic profiling and mutation detection
Our genomic profiling and mutation detection services identify key mutations for personalized therapies. We perform whole genome sequencing (WGS), exome sequencing, and targeted gene panels to deliver insights into SNPs, indels, CNVs, and structural variants.
Molecular analyses in drug development
Molecular analysis across drug development
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
Our services in the discovery phase focus on drug target identification and biomarker discovery. We utilize gene expression profiling and genomic analysis to uncover potential drug targets and identify novel biomarkers associated with disease mechanisms. Leveraging advanced technologies such as NGS, qPCR/dPCR, and proteomics, we discover genetic mutations, gene expression patterns, and early-stage biomarkers that can be validated in later phases of development.
Preclinical
In the preclinical phase, our molecular analysis services validate discovered biomarkers and further characterize genomic mutations identified during the discovery phase. We use qPCR, dPCR, and NGS to confirm biomarkers’ accuracy, reproducibility, and clinical relevance. Additionally, our genomic profiling ensures the integrity of cell and gene therapies, identifying potential mutations or safety risks in therapeutic models before progressing to clinical trials.
Clinical
We leverage qPCR, dPCR, and NGS during clinical trials to support patient stratification, monitor drug efficacy, and ensure safety. qPCR and dPCR provide precise mutation detection and gene expression analysis to assess treatment responses in real-time, while NGS enables comprehensive tracking of therapeutic efficacy and the detection of potential adverse effects, optimizing patient outcomes and ensuring clinical success.
Discovery
Our services in the discovery phase focus on drug target identification and biomarker discovery. We utilize gene expression profiling and genomic analysis to uncover potential drug targets and identify novel biomarkers associated with disease mechanisms. Leveraging advanced technologies such as NGS, qPCR/dPCR, and proteomics, we discover genetic mutations, gene expression patterns, and early-stage biomarkers that can be validated in later phases of development.
Preclinical
In the preclinical phase, our molecular analysis services validate discovered biomarkers and further characterize genomic mutations identified during the discovery phase. We use qPCR, dPCR, and NGS to confirm biomarkers’ accuracy, reproducibility, and clinical relevance. Additionally, our genomic profiling ensures the integrity of cell and gene therapies, identifying potential mutations or safety risks in therapeutic models before progressing to clinical trials.
Clinical
We leverage qPCR, dPCR, and NGS during clinical trials to support patient stratification, monitor drug efficacy, and ensure safety. qPCR and dPCR provide precise mutation detection and gene expression analysis to assess treatment responses in real-time, while NGS enables comprehensive tracking of therapeutic efficacy and the detection of potential adverse effects, optimizing patient outcomes and ensuring clinical success.
Services
Solutions for complex biological challenges
We standardize your custom workflow with a tailed method development. Our approach combines automated, predefined workflows with customized steps, ranging from sample transfer, homogenization, and extraction to downstream applications like NGS library preparation, dilutions, PCR mix preparation, and data interpretation.
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.
From sample to results
Expert in nucleic acid sample preparation and analyses
We specialize in quantifying RNA and DNA with low-copy numbers in diverse biological samples. Our expertise includes RNA/DNA extraction from complex tissues and biofluids, assay design for challenging targets (e.g. highly homologous sequences, short RNAs), and complex data analysis. We offer assay design, validation, and regulatory compliance tailored to your needs, whether for fit-for-purpose or full validation.
Extraction
Sample types
We have experience in DNA and RNA extraction from diverse biofluids and tissues, excreta, LNPs, various sample tools, and biosafety level 1 and 2 agents. We can extract DNA and RNA from fresh, frozen, and fixed tissues and blood with multiple anticoagulants.
Nucleic acid biomarkers
We have extensive experience analyzing nucleic acid biomarkers like genetic SNPs, therapeutic RNA types such as siRNA and mRNA, and short RNAs like miRNA.
High quality data
Assay design is essential, knowing that what you measure mirrors reality. We control every step and adhere to technical standardizations such as the MIQE guidelines, regulatory requirements, and the latest scientific reports to provide the highest data reliability.
method validation
Accelerate drug development with validated assays
Validated assay is essential throughout the entire drug development process.
Assay validation ensures consistent and reliable performance, even with expected variations in conditions. We thoroughly validate each matrix, test item, and PCR assay, ensuring the workflow meets the required criteria, from extraction to sample analysis. The validation level is tailored to the specific context of use.
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
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.
Open PDF Controlling and optimizing steps in extracting RNA from PAXgene® blood RNA tubes significantly improves yield and quality and can lead to more accurate preclinical and clinical conclusions. Blood samples are a critical component of clinical trials, and they
Developing new drugs is a complex and multifaceted process that demands precise, targeted approaches to ensure safety, efficacy, and successful regulatory approval. One of the most critical tools in modern drug development is biomarker testing. Biomarkers are measurable indicators that
T-cell cytotoxicity assays A T-cell cytotoxicity assay, also known as a CD8+ T-cell cytotoxicity assay, measures the ability of cytotoxic T lymphocytes to kill target cells. In drug discovery, this assay helps us understand the immune-modulating actions of new therapeutics
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Let's explore how we can support your drug development program
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