Bioanalytical CRO
Molecular analysis CRO
Services
Solutions for complex biological challenges
We offer a broad range of tailored commissioned services for drug development programs. With over two decades of expertise in nucleic acid analysis and sample preparation, we optimize workflows by assessing sample quality, validating performance, and analyzing clinical biomarkers using leading, well-matched technologies.
PCR for drug development
Reliable sample analysis
With decades of expertise in nucleic acid extraction, assay design, and optimization of PCR and NGS-based methods, we specialize in extracting, detecting, and quantifying nucleic acid targets within complex matrices. We conduct exploratory and clinical biomarker analyses, including bioanalysis services to assess the distribution, persistence, and clearance of foreign nucleic acids and genetically modified cells. Each project is customized to meet the specific needs of the sponsor.
Molecular analyses for cell and gene therapies
We specialize in method development and validation, addressing the unique challenges of biodistribution, viral shedding, pharmacokinetics, and immune monitoring in ATMPs and RNA therapeutics. Our services encompass regulated (GLP, GCLP) and non-regulated research analyses.
Molecular biomarker profiling
We deliver targeted molecular solutions for biomarker discovery, validation, and clinical screenings. Our capabilities include the development, validation, and execution of precise qPCR/dPCR assays for a range of applications, including mRNA, short RNA, cfDNA, and copy number variations. We leverage NGS to analyze gene expression and genetic changes across various tissues and employ affinity-based proteomics for high-throughput plasma analysis.
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 compliance with Good Laboratory Practice (GLP) standards in qPCR, dPCR, and molecular biology. We are Good Clinical Laboratory Practice (GCLP) compliant and ISO/IEC 17025 certified.
Assay validation
Accelerate drug development with validated assays
Development, validation, and analysis of custom PCR assays for pharmacokinetics (PK), biodistribution, and viral shedding.
Our assay validation covers extraction, RT-PCR, and qPCR or dPCR analysis to meet regulatory authorities’ accuracy and precision standards. Our assays detect and quantify rare targets such as cfDNA, viral vector DNA, transgene-expressed mRNA, siRNA, and other drug products and genetic and expressional biomarkers. A validated assay ensures reliable performance throughout the entire drug development program.
A validated assay is a valuable asset
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TWO-Tailed PCR technology
Short RNA with qPCR/dPCR
A TATAA Biocenter innovation that offers validated qPCR/dPCR workflows for siRNA, miRNA, ASOs, and other short nucleic acid targets.
PCR bioanalysis offers several advantages over other methods in speed and throughput; however, standard PCR is unsuitable for short targets due to its length. We have developed a two-tailed primer that enables the optimization, validation, and execution of PCR-based bioanalysis on any short target with high sensitivity and specificity.
Quantitative PCR (qPCR), digital PCR (dPCR), and Next-Generation Sequencing (NGS) are essential technologies in siRNA bioanalysis. They provide the precise quantification, sensitivity, and specificity needed to track siRNA’s therapeutic efficacy, stability, and biodistribution. Application note: siRNA assays in bioanalysis (PDF)
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
Biodistribution assays conducted in accordance with ICH S12 guidelines. Biodistribution aims to understand the distribution of therapeutic genetic material in various target and non-target tissues in cell and gene therapies. This data is crucial for correlating with mRNA expression data
About us
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, our mission is to push the boundaries of science and technology to generate accurate and reproducible data that shortens time-to-market.
Regulated laboratory environment
We are GLP accredited for qPCR, dPCR, and molecular biology, GCLP compliant, and ISO/IEC 17025 accredited. Our facility features a strict sample management process, a fully integrated LIMS system, backup for all vital systems, temperature and humidity control, and robust IT security.
Purpose-built PCR laboratory
Our purpose-built laboratory in Gothenburg, Sweden, is specifically designed for PCR. It has controlled air pressure, temporal separation, and biosafety cabinets to minimize contamination risk. This setup enables us to achieve the highest sensitivity and robustness required for validated assays. The lab is equipped with market-leading PCR and NGS instruments and advanced liquid handling systems.
Pioneers in assay development and validation
We are a team of 45 employees, with scientists at the forefront of assay development, optimization, and validation. Our team has co-authored key publications in the field, including Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development (AAPS J. 2024) and The MIQE Guidelines for qPCR and dPCR.
Flexible, client-centered solutions
We work closely with our clients to find tailored solutions, offering flexibility in sample types, test items, sample volume, and scalability. We prioritize transparency and proactive communication throughout each project, ensuring our clients are continuously updated on the progress.
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Let's explore how we can support your drug development program
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