Capability guide
Molceular bioanalysis CRO
TATAA Biocenter is a CRO specializing in molecular analysis, offering expertise in developing, optimizing, and validating assays for various biomarker analyses and bioanalysis for advanced therapies.
Molecular services
Supporting drug development
Gene therapies (in vivo) | ||
| Technique | Capability | Analytical outcome |
| qPCR | • Biodistribution | Precise quantification of vector copy numbers and transgene expression in tissues, as well as viral copy numbers in shed material. |
| • Shedding | ||
| • Vector copy number | ||
| • Transgene expression | ||
| • Pharmacokinetics (PK) | ||
| dPCR | • Biodistribution | Absolute quantification of low-abundance targets, vector DNA/RNA for shedding studies, biodistribution, and PK profiles. |
| • Shedding | ||
| • Vector copy number | ||
| • Transgene expression | ||
| • Pharmacokinetics (PK) | ||
| DNA-seq | • Vector copy number | Monitor vector integration sites and genome integrity after gene delivery. |
| • Integration site analysis | ||
| • Mutation detection | ||
| RNA-Seq | • Transgene expression | Quantify mRNA levels to assess the success of transgene expression and gene modulation. |
| • Gene modulation | ||
| Immunoprofiling | • Immune response monitoring | Multiplexed absolute quantification of key cytokines and other essential immunological proteins. |
| • Immunotoxicity | ||
| • Cytokine profiling | ||
Gene therapies (ex vivo) | ||
| Technique | Capability | Analytical outcome |
| qPCR | •Vector copy number | Precise quantification of transgene expression and vector persistence. |
| •Transgene expression in modified cells | ||
| dPCR | •Transgene expression | Absolute quantification of transgene levels and vector integration accuracy. |
| •Vector integration | ||
| •Off-target analysis | ||
| DNA-seq | •Vector copy number | Monitor integration sites and potential off-target effects in modified cells. |
| •Integration site analysis | ||
| •Genetic modifications | ||
| RNA-Seq | •Transgene expression | Quantify transgene expression and any unintended effects on other genes. |
| •Gene modulation in reintroduced cells | ||
| Immunoprofiling | •Immune response monitoring | Evaluates immune response to reintroduced cells. |
| •Cytokine Release Syndrome (CRS) | ||
| TCR/BCR Seq | •Immune repertoire analysis, | Track immune receptor diversity and persistence of engineered immune cells. |
| •Immune cell persistence | ||
CAR-T/NK cell therapies | ||
| Technique | Capability | Analytical outcome |
| qPCR | •Vector copy number | Precise quantification of vector copy numbers, transgene expression, and CAR-T cell persistence |
| •Transgene expression | ||
| •CAR-T cell quantification | ||
| dPCR | •Low-level transgene detection | Absolute quantification of transgenes in modified cells and biofluids, tracking long-term persistence. |
| •CAR-T persistence | ||
| DNA-seq | •Vector copy number | Monitor vector integration into T or NK cells and check for off-target genome modifications. |
| •Integration site analysis | ||
| •Off-target effects | ||
| RNA-Seq | •Transgene expression | Measure transgene expression and track changes in gene expression in engineered cells. |
| •Gene modulation | ||
| •CAR/NK persistence | ||
| Immunoprofiling | •Immune response monitoring | Detects levels of inflammatory cytokines, which is critical for managing CRS and immunotoxicity risks. |
| •Cytokine Release Syndrome (CRS) | ||
| TCR/BCR Seq | •Immune repertoire analysis, | Track the persistence and clonal expansion of CAR-T cells. |
| •Monitoring clonal expansion of CAR-T cells | ||
CRISPR gene editing therapies | ||
| Technique | Capability | Analytical outcome |
| qPCR | •Target gene detection | Precise quantification of on-target and off-target gene edits, ensuring accurate gene correction. |
| •Integration efficiency | ||
| •Off-target validation | ||
| dPCR | •Low-level mutation detection | Absolute quantification of low-abundance edits or off-target modifications. |
| •Off-target analysis | ||
| •Gene copy quantification | ||
| DNA-seq | •Off-target effects | Identify off-target modifications, verify correct genome edits, and check for unintended mutations |
| •Integration site analysis | ||
| •Mutation detection | ||
| RNA-Seq | •Gene expression changes | Analyze gene expression changes after editing, and monitoring transgene expression. |
| •Transgene expression | ||
| •Editing efficiency | ||
| Immunoprofiling | •Immune response monitoring | Immune activation or suppression in response to CRISPR-edited cells. |
| •Inflammatory response | ||
| TCR/BCR Seq | •Immune repertoire analysis, | Track changes in immune receptor diversity after gene editing, especially in immunogenic contexts |
| •Immune response to gene editing | ||
Antisense oligonucleotides (ASOs) | ||
| Technique | Capability | Analytical outcome |
| qPCR | •mRNA knockdown validation | Validate the level of target mRNA knockdown and quantifies gene expression changes following ASO therapy. |
| •Gene expression analysis | ||
| dPCR | •Low-level mRNA detection | Absolute quantification of low-abundance mRNA species and confirmation off-target knockdown. |
| •Off-target analysis | ||
| •Quantification | ||
| DNA-seq | •Mutation detection | Detect mutations and ensures that ASO therapy does not unintentionally affect the genome. |
| •Off-target effects | ||
| •Genomic integrity | ||
| RNA-Seq | •mRNA knockdown efficiency | Measure the efficiency of ASO-mediated mRNA knockdown and analyze potential off-target RNA effects. |
| •Transcriptome-wide effects | ||
| •Off-target RNA | ||
| Immunoprofiling | •Immune response monitoring | Assess immune reactions or inflammatory responses due to ASO treatment. |
| •Inflammatory response | ||
Modified RNA therapies | ||
| Technique | Capability | Analytical outcome |
| qPCR | •Transgene expression | Validate transgene expression levels and RNA integrity, providing insights into dose-response relationships. |
| •RNA integrity | ||
| •Dose response | ||
| dPCR | •Low-level RNA detection | Precise quantification of low-abundance RNA species and tracked RNA stability over time. |
| •Stability monitoring | ||
| •Transgene quantification | ||
| DNA-seq | •Mutation detection | Ensure that modified RNA therapy does not induce genomic changes or unintended mutations. |
| •Off-target effects | ||
| RNA-Seq | •Transgene expression | Monitor modified RNA expression, assess stability of delivered RNA, and evaluate transcriptome-wide effects. |
| •Gene modulation | ||
| •RNA stability | ||
| Immunoprofiling | •Immune response monitoring | Detect immune responses or inflammation triggered by the modified RNA therapy. |
| •Inflammatory response | ||
Other modalities | ||
| Technique | Capability | Analytical outcome |
| qPCR | •Target gene expression | Quantify target gene expression and downstream effects on molecular pathways. |
| •Pathway modulation | ||
| •Bioanalysis | ||
| dPCR | •Low-level detection of gene expression | Precise detection of low-abundance mRNA and identification of off-target gene expression changes. |
| •Off-target effects | ||
| •Bioanalysis | ||
| DNA-seq | •Mutation detection | Detect mutations or genomic alterations that may arise due to the therapy. |
| •Genomic instability | ||
| RNA-Seq | •Gene expression modulation | Examine transcriptome-wide changes due to small molecule treatment, and identify dose-dependent responses. |
| •Off-target effects | ||
| •Dose response | ||
| Immunoprofiling | •Immune response monitoring | Assess immune activation and inflammatory response as a result of the therapy. |
| •Inflammatory response | ||
| Proteomics | •Target engagement | Multiplexed quantification of selected pathways to monitor the interaction between the therapy and its target protein, while assessing downstream signaling pathways. |
| •Mechanism of action | ||
| •Pathway analysis | ||
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, our mission is to push the boundaries of science and technology to generate accurate and reproducible data that shortens time-to-market.
Custom solutions
We customize solutions based on sample type(s), number of test items, sample volume, level of automation, regulatory requirements, and context of use. Our flexible approach focuses on delivering quality data to support your decision-making.
Nucleic acid experts
As a niche CRO, we specialize in nucleic acid extraction, assay development, and validation of nucleic acid quantification. With our extensive experience, we deliver expert solutions that accelerate method development and provide reliable, high-quality data you can trust.
Compliance
We are GLP-accredited by SWEDAC, GCLP-compliant, and ISO/IEC 17025 accredited, ensuring a robust quality management system. This includes secure data storage, power backup, precise monitoring of humidity and temperature, rigorous sample management processes, full traceability, and a team of skilled, qualified personnel.
Infrastructure
We operate in a state-of-the-art, purpose-built laboratory with dedicated areas, controlled air pressure, and optimized workflows to minimize contamination risks. Our facility is equipped with industry-leading qPCR, dPCR, and NGS platforms and advanced automated liquid handling systems for automated sample transfer, assay mixing, dilution, extraction, and library preparation.
contact
Let's explore how we can support your drug development program.
One form for all pages, including link to mailchimp.
"*" indicates required fields
