Pathogen detection

We offer NGS and PCR-based pathogen detection assays with short lead times to accelerate process decisions.

Pathogen detection approaches

We develop assays for detecting pathogenic oncogenes or microbial contamination during production.

This risk of contamination is a constant concern in the production of cell and gene therapies, primarily because it’s impossible to sterilize the cells used in production or the raw materials. To minimize the risk of infection, it is crucial to utilize well-characterized cell lines that do not carry endogenous viruses with the potential to induce tumorigenesis. These cell lines must undergo testing for human pathogenic viruses such as HIV, Hepatitis B (HepB), Human Papillomavirus (HPV), Epstein-Barr Virus (EBV), and Cytomegalovirus (CMV).

At TATAA Biocenter, we can help screen for oncogenic sequences in cells used in production. In the case of autologous cells, extensive screening may only be necessary if the bioprocessing procedures increase the risk of oncogenic events.

Furthermore, the manipulation of cells carries a high risk of microbial contamination. In controlled engineering facilities, most organisms typically originate from the commensal flora of personnel, which is generally considered nonpathogenic but can lead to clinically significant infections in individuals with compromised immune systems. The most common microbial contaminants include mycoplasma, bacteria, and fungi. Detecting unidentified microbial contaminant species poses a challenge, and one potential solution is to consider 16S rRNA screening for prokaryotic contamination and 18S rRNA screening for eukaryotic contamination.

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
Lines in Circle Mask - Lg
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.


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.

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.

Viral shedding assays presents unique challenges. The analytes released are typically found in very low quantities, and the matrices involved in shedding assays often contain significant levels of PCR inhibitory agents and endogenous DNA. Our shedding services The FDA requires

Recommendation and analysis of shedding studies by the FDA Shedding assays require optimized extraction protocols tailored for each sample type and an accurate qPCR/dPCR assay with the necessary sensitivity and specificity. This ensures that shed products are detected and the

Short oligonucleotide modalities like siRNA, miRNA, and ASO are designed to modulate gene expression by targeting mRNA, silencing or activating gene expression, or altering splicing patterns. PCR-based technologies are the standard for bioanalytics, including biodistribution studies during cell and gene

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.


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.