accelerate process development

Integration site analysis

We offer PCR and NGS-based integration site analysis with short lead times to accelerate process decisions.

Integration site analysis in gene therapies

We identify the integration loci and number of integrated vectors in the target genome through quantitative PCR and NGS.

Conducting gene integration analysis is essential to ensure the safety of integrating viruses like lentiviruses and other gene therapies involving inserted sequences or gene editing techniques like CRISPR. This analysis evaluates the specificity of integration sites for each construct.

Theoretically, integrating genetic material into a target cell poses a risk of transformation through knock-out, modulation, or over-expression of adjacent genes at the integration site, potentially leading to oncogenicity. Therefore, controlling the level of transduction and the integration sites within the manufacturing process is crucial. The risk associated with integration is correlated with the amount of vector input used in the production and the vector copy number per transduced cell.

Gene therapy and cell therapy products commonly use lentiviral-derived vectors (LVVs) for delivering transgenic material due to their versatility, stable and long-term gene expression. LVVs, typically based on HIV-1 retroviruses, can transport transgenic material of up to 10kb compared to the AAV, which can transport 4.7 kb. 

In recent years, gene editing techniques, such as transcription activator-like effector nucleases (TALENs) and CRISPR, have gained significant traction. These methods allow editing of mutations, targeting specific gene loci or genomic safe harbors (GSHs) within the genome to ensure that newly inserted genetic elements function predictably without causing alterations to the host genome or posing a risk of mutagenesis.

Nonetheless, evaluating the integration site specificity for each construct as part of safety assessments remains essential. Integration site analysis is conducted using next-generation sequencing. Meanwhile, the number of integrations per transduced cell, referred to as the vector copy number, is typically assessed using a quantitative PCR technique.

Accelerate production with TATAA

We offer short lead times and fast analyses, allowing you to optimize the purification process, provide confidence in your products before GMP analysis, help with deviation control, and ensure trust in GMP results and safe product delivery.

Our well-equipped molecular analysis laboratory features automated platforms, a Laboratory Information Management System (LIMS), and high-throughput instruments for qPCR, dPCR, and Next-Generation Sequencing (NGS). Additionally, our facility includes a Biosafety Level 2 (BSL-2) laboratory that allows us to offer end-to-end solutions, from sample extraction to data transfer.

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
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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.

QUALITY ANALYSES

Accelerate with reliable results

With over 20 years of experience in nucleic acid analysis, we specialize in developing PCR-based assays that offer fast, accurate, and reliable quality testing for process optimization. The rapid results generated by PCR technology make it well-suited for assays on viable products, crucial for cell and gene therapies.

Vector copy number

Quantifying the transgene dosage, the presence of transgenes, the number of integrated vectors, or the number of non-integrated vector genomes in targeted cells provides essential information during production optimization.

Host cell DNA residuals

We use PCR approaches to detect DNA impurities from host production cells or plasmids used for transfection in gene therapy viral vector production.

Vector Integrity TATAA Biocenter
Vector integrity​

Ensuring consistent characterization of the packaged vector genome is crucial for production process optimizations and comparing results across production batches.

Pathogen Detection TATAA Biocenter
Pathogen detection

Various sequencing technologies provide a fast and reliable tool for evaluating sterility and detecting mycoplasma and endotoxins.

Biodistribution aims to understand the distribution of therapeutic genetic material in various target and non-target tissues. This data is crucial for correlating with mRNA expression data to determine optimal dose strategies, refine vector constructs, and interpret pharmacology and toxicology data.

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. Explore Our Olink Services The Olink Target 96 panels simultaneously enable high-multiplex targeting

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

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.