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.
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, manufacturing quality assays, 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.
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.
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
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.
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Our technologies
qPCR and dPCR
We develop and validate sensitive dPCR/qPCR assays to quantify genetic, RNA, and miRNA biomarkers, VCN, SNPs, and SNVs, as well as biodistribution, kinetics, and shedding assays across diverse sample types in all phases of drug development.
Extraction
We have extensive experience extracting various nucleic acids, including DNA, cfDNA, short RNAs (miRNA, siRNA), mRNA, and modified ASOs, from different sample types such as tissues, biofluids, swabs, excreta, secreta, and FFPE-fixed materials.
RNA-seq
We offer RNA sequencing solutions from sample extraction to biostatistical analysis for total RNA and mRNA-seq, including tag-based approaches like 3′-mRNA sequencing and small RNA-seq.
Assay 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.
DNA-seq
We sequence the whole genome, exome, or targeted panels to uncover genetic variations, discover drug targets, understand disease mechanisms, stratify patients, and identify predictive or prognostic biomarkers, all at the DNA level.
Affinity-based proteomics
We are a certified Olink service provider, offering Olink protein panels that cover disease pathways, therapeutic responses, and immune response monitoring using only microliters of plasma or serum.
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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