Detecting viral and transgene genetic material
A CRO specializing in ATMPs
We excel in regulated bioanalysis and biomarker profiling in the development of gene editing and nucleic acid-based therapies (ATMPs)
Comprehensive support for the development of Advanced Therapy Medicinal Products (ATMPs)
Non-integrating vectors
We assess vector copy number (VCN), transgene expression and conduct bioanalysis to ensure safety and efficacy. We also monitor long-term effects and potential unintended integration events.
Integrating vectors
We run assays to assess vector integration, vector latency, and vector persistence to ensure safety and efficacy, as well as to monitor long-term therapeutic effects.
Gene editing therapies
We analyze the specificity and efficiency of the gene editing process, the potential for off-target effects, and unintended genome changes on both ex vivo and in vivo samples.
Oncolytic virus therapies
We use highly sensitive analytical techniques like qPCR to assess viral load, viral replication, and conduct bioanalysis, ensuring the patient’s safety, efficacy, and long-term therapy monitoring.
applications for ATMPs
Solutions for complex ATMP challenges
We offer a comprehensive range of tailored services for ATMP development programs. With over two decades of expertise in nucleic acid analysis and sample preparation, we excel in sample extraction and quality assessment, method development and validation, and analyzing biomarkers using leading, well-matched technologies.
Bioanalysis
- PK/PD
- BIODISTRIBUTION
- SHEDDING
- TRANSGENE EXPRESSION
Manufacturing QAs
- INTEGRATION SITE ANALYSIS
- VECTOR COPY NUMBER
- HOST CELL DNA RESIDUALS
- VECTOR INTEGRITY
- PATHOGEN DETECTION
Biomarker profiling
- BIOMARKER DISCOVERY
- GENOMIC BIOMARKERS
- GENE EXPRESSION ANALYSIS
- QUANTITIVE PROTEIN ASSAYS
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Let's explore how we can support your ATMP program
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Molecular analyses in ATMP development
Support at every phase for well-informed decisions
We accelerate time-to-market with rapid and reliable data, enabling informed stage-gate decisions and preparing submission-ready reports. We excel at identifying and monitoring nucleic acid biomarkers essential for understanding target engagement, efficacy, potency, and safety of ATMPs.
In early discovery, we identify valuable biomarkers for candidate selection, lead optimization, and patient stratification. In addition, we run quantitative analyses to provide the necessary data for vector evaluation and optimization, including tissue specificity and potency for lead candidate selection.
We offer a spectrum of assay validation for regulatory filings and confident decision-making, ranging from fully validated assays to fit-for-purpose assays for covering various bioanalyses, including PK/PD, biodistribution, and viral shedding.
With a state-of-the-art instrumentation fleet, automated platforms, and an integrated Laboratory Information Management System (LIMS), we conduct high-throughput analysis of clinical nucleic acid biomarkers for patient stratification, efficacy, and safety endpoint.
Discovery
In early discovery, we identify valuable biomarkers for candidate selection, lead optimization, and patient stratification. In addition, we run quantitative analyses to provide the necessary data for vector evaluation and optimization, including tissue specificity and potency for lead candidate selection.
Preclinical
We offer a spectrum of assay validation for regulatory filings and confident decision-making, ranging from fully validated assays to fit-for-purpose assays for covering various bioanalyses, including PK/PD, biodistribution, and viral shedding.
Clinical
We use the highest quality reagents, adhere to dedicated controls, standardize and harmonize all processes per technical requirements like the MIQE guidelines. We deliver rapid, robust and reproducible results that are submission-ready.
compliant bioanalysis
Accurate and reproducible data
GCLP-compliant and ISO/IEC 17025 accredited laboratory
TATAA Biocenter is accredited by the Swedish Board of Accreditation and Conformity Assessment (SWEDAC) for complying with ISO/IEC 17025 standards. We also adhere to Good Clinical Laboratory Practice (GCLP) guidelines, which are international quality standards governing the analysis of samples from clinical trials.
GCLP validation is mandatory to demonstrate the accuracy, reliability, and consistency of clinical assays. The standards cover all aspects of laboratory work in clinical studies, including study planning, execution, monitoring, documentation, archiving, and reporting. This rigorous process assures both the sponsors when submitting data for new ATMP approvals, and regulatory authorities when reviewing the data, that it is generated in a standardized manner.
From sample to results
Expert in nucleic acid sample preparation and analyses
We specialize in quantifying RNA and DNA with low-copy numbers in diverse biological samples. Our expertise includes RNA/DNA extraction from complex tissues and biofluids, assay design for challenging targets (e.g. highly homologous sequences, short RNAs), and complex data analysis. We offer assay design, validation, and regulatory compliance tailored to your needs, whether for fit-for-purpose or full validation.
Extraction
Sample types
We have experience in DNA and RNA extraction from diverse biofluids and tissues, excreta, LNPs, various sample tools, and biosafety level 1 and 2 agents. We can extract DNA and RNA from fresh, frozen, and fixed tissues and blood with multiple anticoagulants.
Nucleic acid biomarkers
We have extensive experience analyzing nucleic acid biomarkers like genetic SNPs, therapeutic RNA types such as siRNA and mRNA, and short RNAs like miRNA.
High quality data
Assay design is essential, knowing that what you measure mirrors reality. We control every step and adhere to technical standardizations such as the MIQE guidelines, regulatory requirements, and the latest scientific reports to provide the highest data reliability.
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.
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.
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.
contact us
Let's explore how we can support your ATMP program
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