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

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.

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.

Integation Site Analysis TATAA Biocenter
Integration site analysis

We evaluate the integration site specificity and transduction efficiency, assess safety, and prevent unintended effects on adjacent genes during integration.

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.

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.