ACCELERATE PRODUCTION
Vector copy number assays
We offer PCR-based vector copy number assays with short lead times to accelerate process decisions.
VCN in cell and gene therapies
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.
compliant bioanalysis
Accurate and reproducible data
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.
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.
Open PDF Controlling and optimizing steps in extracting RNA from PAXgene® blood RNA tubes significantly improves yield and quality and can lead to more accurate preclinical and clinical conclusions. Blood samples are a critical component of clinical trials, and they
Developing new drugs is a complex and multifaceted process that demands precise, targeted approaches to ensure safety, efficacy, and successful regulatory approval. One of the most critical tools in modern drug development is biomarker testing. Biomarkers are measurable indicators that
T-cell cytotoxicity assays A T-cell cytotoxicity assay, also known as a CD8+ T-cell cytotoxicity assay, measures the ability of cytotoxic T lymphocytes to kill target cells. In drug discovery, this assay helps us understand the immune-modulating actions of new therapeutics
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.
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
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
We use NGS, a powerful tool to sequence entire exomes, genomes, or transcriptomes, and our scientists and bioinformaticians provide comprehensive sequencing data.
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.
contact us
Let's explore how we can support your drug development program
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