GENOMICS AND TRANSCRIPTOMICS

Next generation sequencing

We run NGS services for exploratory, bioanalytical, vector integrity, or safety assessments.

NGS technologies

NGS is an exciting technology for biomarker profiling in precision medicines and drug product characterization for cell and gene therapies. NGS is a large-scale, rapid, and efficient DNA or RNA sequencing technology.

Next-generation sequencing (NGS) is a powerful technology used to sequence the entire nucleic acid sequence within various biological samples. NGS includes sequencing the complete transcriptome, exome, genome, or specific targeted sequences. Unlike PCR, which requires prior knowledge of the primer and probe design target sequence, NGS strategies can determine the sequence of unknown samples.

In short-read sequencing, we fragment DNA into pieces, add adapters, and then sequence the fragments in parallel on a massive scale. We use computational alignment to assemble the complete transcriptome, exome, or genome. This approach is cost-effective and provides high accuracy compared to traditional Sanger sequencing.

NGS is particularly valuable for transcriptomics, microbiome analysis, and quality assessments. The sequencing depth generates a large number of reads, which not only provides sequencing data but also yields quantitative data. The relative comparison of expressed RNA provides insights into understanding pathway activations, mode of action, target engagement, and potential off-target effects.

NGS is commonly used in biomarker discovery because it can simultaneously analyze multiple genes or transcripts, offering a holistic perspective on the molecular changes linked to a specific disease or treatment. It identifies novel biomarkers, provides insights into the underlying disease mechanisms, and quantifies the biological impacts of therapeutic interventions.

Targeted amplification NGS is employed for identity testing and assessing critical quality attributes (CQAs) in cell and gene therapy products. It enables verification of gene integration sites, determination of gene copy numbers in cell therapy products, and analysis of the potential for insertional mutagenesis, among other applications.

NGS-based biosafety assays offer rapid, accurate, and high-throughput detection of contamination by adventitious agents like bacteria, mycoplasma, and viruses. NGS provides a broader detection range than existing methods, allowing for targeted and untargeted adventitious agent detection.

NGS SERVICES AT TATAA

TATAA Biocenter has years of experience running NGS applications backed by a wide array of NGS instruments for various applications. Our skilled scientists have expertise spanning sample extraction, NGS methodology selection, and execution. Our experienced bioinformaticians excel at the data processing and statistical analysis of intricate NGS data.

Optimization is our priority, with quality control measures implemented at each stage of processing to assess the suitability of samples for library preparation, the quality and quantity of prepared libraries, and confirmation of premium sequencing output.

We tailor our services to match your objectives and requirements, from experimental designs to data analysis. Furthermore, we offer outstanding scalability options, accommodating projects of varying sizes and complexities. Whether you are embarking on small-scale research or large-scale genomics initiatives, we can effectively meet your needs.

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.

drug development TATAA Biocenter
Lines in Circle Mask - Lg
method validation

Accelerate drug development with validated assays

Validated bioanalysis is essential throughout the entire drug development process.

Conducting fit-for-purpose validations in the initial stages of discovery is key. These validations offer valuable insights of expected assay performance before undertaking more comprehensive method validation processes. A validated PCR assay is essential to ensure the accuracy and reliability of results and ensures that the assay meets the client’s needs, study requirements, and assay criteria under defined operating conditions. Our assay validations ensure dependable data for making stage-gate decisions and preparing regulatory filings.

A validated assay is a valuable asset.

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.

Olink service provider TATAA Biocenter
Quantitative proteomics

We are a designated Olink service provider with the latest technologies for running quantitative proteomics using Olink’s panels for biomarker discovery, validation, and screening.

The Olink Target 96 panels are designed for high throughput, cost efficiency, and low sample consumption, facilitating targeted biomarker research in various disease areas and biological processes. The Olink Target 96 panels simultaneously enable high-multiplex targeting analysis of 92 protein

The Olink Explore 384 panels collectively form the comprehensive Explore 3072 panel. Run one or several of these panels on each sample simultaneously. Each Olinke 384 panel contains carefully selected proteins validated for human plasma and serum samples, making it

The Explore HT panel contains over 5,400+ proteins, almost twice as many as the Explore 3072 panels. The sample volume for Explore HT is 2 µl, compared to 6 µl for Explore 3072. The workflow for Explore HT is four

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

We are ahead of industry trends and always updated on the regulatory landscape and requirements for gene editing and nucleic acid-based therapies. Our purpose is to provide data that’s easily auditable.

Total project transparency

We maintain transparency and proactively communicate throughout the project, ensuring our clients always stay updated on the progress. Transparency forms the cornerstone of our proven client model.

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.

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Let's explore how we can support your drug development program

PK/PD​ bioanalysis

General NGS Page

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