ACCELERATE PRODUCTION
Vector copy number assays
We offer PCR-based vector copy number assays with short lead times to accelerate process decisions.
Vector copy number is all about balancing efficacy against safety. More copies will increase efficacy but also the potential risk of oncogenesis. We quantify the vector copy number for dosing, potency, and safety assessments.
Vector copy number (VCN) represents the quantity of transgene DNA in genetically modified cells or viral gene therapy products before administration. The FDA raises concerns about potential oncogenicity due to the risk of pathological insertions associated with vector-mediated genetic modification. To address these safety concerns, measuring transgene copies within cell therapy products and quantifying the VCN is required. More integrated transgene copies are believed to enhance product potency as well as increase the oncogenic potential by random vector integration into the host genome. Therefore, the objective is to balance an effective VCN with minimizing associated risks.
FDA approval for clinical use mandates limiting CAR-T VCN to fewer than five vector copies per transduced cell, reducing the number of vector insertion sites in the host genome.
For in vivo administered viral gene therapy products, accurate quantification of the viral genome titer is crucial for dosing and potency analysis. To assess VCN persistence in cell therapies and in vivo administered viral gene therapies, various techniques such as qPCR, dPCR, or NGS are employed to amplify integrated viral vector sequences in genomic DNA obtained from biospecimens. These analyses contribute to gene therapy products’ overall safety and efficacy assessment.
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.
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.
Integration site analysis
We evaluate the integration site specificity and transduction efficiency, assess safety, and prevent unintended effects on adjacent genes during integration.
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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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General Vector copy number Page
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