SENSITIVE AND RELIABLE DETECTION
Quantitative and digital PCR services
Our team of experts offers comprehensive method development and validation services, ensuring reliable and reproducible results. qPCR and dPCR provide exceptional sensitivity, making them ideal for detecting low-abundance targets such as viral vectors, gene edits, SNPs/SNVs, ctDNA, MDR, and copy number variations. These techniques are well-suited for high-throughput analysis and can be highly automated.
Nucleic acid experts
Two decades of PCR expertise
Quantitative PCR is at the core of our business, with over 20 years of experience in assay design, including extraction, validation, and sample analysis. We offer a range of instruments that support everything from small sample batches to near-fully automated high-throughput analysis, capable of processing tens of thousands of samples under GLP and GCLP-compliant conditions.
Method development and validation
We develop and optimize qPCR/dPCR assays to achieve the accuracy, precision, and robustness required to meet the validation criteria. Validation covers the extraction process, RT-PCR (for RNA), and qPCR/dPCR assay, ensuring the generated data is reliable.
Custom solutions
We develop tailored assays to meet client needs, whether for challenging matrices or complex test items. Based on sample volume, validation requirements, automation level, and timelines, we provide genuinely flexible solutions.
Extraction services
We optimize extraction to ensure that the test item achieves the necessary yield, quality, and integrity for downstream applications, with complete control over potential inhibitory effects on PCR.
Compliance
We are GLP accredited for dPCR, qPCR, and molecular biology, GCLP compliant, and ISO/IEC 17025 certified, ensuring rigorous sample handling, thorough documentation, robust IT security, and reliable backup systems.
Regulatory support
Our team of scientists is at the forefront of advanced PCR services. As co-authors of the 2024 publication Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development in AAPS Journal, we lead the field in qPCR/dPCR validation in cell and gene bioanalysis.
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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
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.
TWO-Tailed PCR technology
Short RNA quantification 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.
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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