Bioanalytical CRO
Pioneering PCR innovation at scale
Bioanalytical services
Supporting drug development
At the cutting edge of bioanalysis and biomarker discovery, we specialize in developing and validating advanced assays for ATMP (Advanced Therapy Medicinal Products) bioanalysis and clinical biomarkers across diverse matrices. With over 20 years of expertise in extraction methods and assay design, coupled with a state-of-the-art laboratory, we offer comprehensive, end-to-end workflows. Our services range from customized biodistribution studies and targeted biomarker discovery to large-scale clinical biomarker screenings, ensuring precision and accuracy at every stage of drug development.
By combining deep scientific expertise with innovative technologies like qPCR, dPCR, NGS, and Olink, we provide tailored solutions that support your Cell and Gene Therapy (CGT) and precision medicine programs, ensuring your therapy’s success in both preclinical and clinical phases.
Biomarker analysis
With validated assays and workflows, we offer comprehensive services for analyzing molecular biomarkers from biological samples, supporting early and late development stages, translational medicine, and clinical GCLP screenings. We capture detailed phenotypic data through genomics, transcriptomics, and Olink proteomics, alongside targeted quantification using qPCR/dPCR. With years of expertise, we accelerate method development, assay validation, and sample analysis from your tissue of interest.
Cell and gene therapy bioanalysis
We specialize in bioanalysis for cell and gene therapy, offering comprehensive services including assay design and validation for biodistribution, shedding, and immunoprofiling. Our team optimizes the extraction of your test items from any biological matrix, ensuring that assays are validated in line with regulatory standards and meet set acceptance criteria. Additionally, we conduct PCR-based bioanalysis on short nucleic acids, such as siRNA, miRNA, and ASOs, utilizing advanced Two-Tailed PCR technology.
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 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.
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.
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 assays 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 entire 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 an 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
technologies
We operate with the latest technologies
TATAA Biocenter comprises highly skilled scientists with extensive expertise in method development, data analysis, and optimization across diverse technologies. We leverage top-notch instrumentation and automated platforms, offering expert guidance to choose the most suitable technology on the market 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 automated, customized workflows tailored to the sample type to simultaneously analyze thousands of genes, whole genomes, and either targeted RNA or full transcriptomes for both small and large-scale studies.
Quantitative proteomics
Olink’s proximity extension assays (PEA) allow multiplexed analysis of hundreds to thousands of proteins using just microliters of blood or plasma, ideal for immune studies and biomarker discovery or validation.
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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