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.
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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
Ensuring consistent characterization of the packaged vector genome is crucial for production process optimizations and comparing results across production batches.
Pathogen detection
Various sequencing technologies provide a fast and reliable tool for evaluating sterility and detecting mycoplasma and endotoxins.
Primer dimer test Primer-dimers can bias qPCR results, so a test for primer-dimers should be performed during assay development to ensure that only the target sequence is amplified and quantified. The effect of primer dimers Checking for primer dimers is
TCR sequencing TCR sequencing on DNA or RNA is used to understand anti-tumor immune responses and to track responses to infections, vaccinations, and immunotherapies. Our TCR sequencing services Ask a question What is a T-cell receptors (TCRs)? T-cell receptors (TCRs)
Pharmacokinetics (PK) in gene therapies Pharmacokinetics for genes introduced by gene therapies is more challenging than those of finished small molecules. Our custom assays for biodistribution, pharmacokinetics (PK), and shedding. Ask a question Pharmacokinetics (PK) in gene therapies Pharmacokinetics for
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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