Advancing PCR bioanalysis

Molecular analysis CRO

Our mission is to provide you with data that accurately reflects the performance of your gene therapy product or construct, enabling impactful, informed decisions.

Vector DNA, siRNA, messenger RNA

Detection of viral and transgene RNA and DNA analytes

With over 20 years of experience, we address the most complex challenges in ATMP bioanalysis with precision and expertise. We prioritize quality, innovation, and building strong client relationships to tailor assays to your needs and regulatory requirements.

Molecular analysis for cell and gene therapies

We optimize extractions from your preferred tissues or biofluids and select the appropriate analysis technology based on the context of use (COU). Our team designs, optimizes, qualifies, and validates primers and probes for various applications, like biodistribution, shedding, and gene expression assays.

Clinical biomarker profiling

We employ next-generation sequencing to discover nucleic acid biomarkers and utilize various PCR-based technologies for targeted, high-throughput quantification of clinical biomarkers. As an Olink-approved service provider, we offer highly multiplexed, quantitative proteomics panels.

Molecular analyses in drug development

Support at every phase for well-informed decisions

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.

ATMP
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 validations for regulatory filings and confident decision-making, ranging from fully validated assays to fit-for-purpose assays for various bioanalyses, including biodistribution and messenger RNA detection.

Clinical

With regulated sample management processes, a state-of-the-art instrumentation fleet, automated platforms, and an integrated Laboratory Information Management System (LIMS), we conduct high-throughput analysis of tailored, GCLP-compliant assays for clinical nucleic acid biomarkers.

ATMP
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.

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.

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.

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 Analysis TATAA Biocenter
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 Services TATAA Biocenter
NGS

We use NGS, a powerful tool to sequence entire exomes, genomes, or transcriptomes, and our scientists and bioinformaticians provide comprehensive sequencing data.