Bioanalysis
Bioanalytical CRO for cell and gene therapies
We specialize in PCR bioanalysis for the development of gene editing and nucleic acid-based therapies.
BIOANALYTICAL SERVICES
Quantification of viral and transgene RNA and DNA
With more than two decades of experience in extraction and PCR assay design, we develop, optimize, qualify, and validate assays for the bioanalysis of nucleic acid test items such as siRNA, miRNA, messenger RNA, encapsulated viral DNA, and more in various biological matrices.
Biodistribution
We monitor the biodistribution of small non-coding RNA, viral vectors, and mRNA vaccines within the body using validated PCR methods.
Shedding
We quantify shed viruses, bacteria-based gene therapy products, or oncolytic products in sweat, urine, excreta, and various body fluids.
PK/PD
PK/PD analytes, including vector DNA, transgene DNA, or transgene RNA, are extracted and quantified using validated PCR methods to determine the PK and PD profiles.
Transgene expression
We quantify transgene RNA, derived from foreign genetic material, as a surrogate marker for protein expression and correlate it with bioanalysis for dosage optimization.
Manufacturing quality assessments
We quantify transgene RNA, derived from foreign genetic material, as a surrogate marker for protein expression and correlate it with bioanalysis for dosage optimization.
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Services
Solutions for complex biological challenges
We offer a broad range of tailored commissioned services for drug development programs. With over two decades of expertise in nucleic acid analysis and sample preparation, we optimize workflows by assessing sample quality, validating performance, and analyzing clinical biomarkers using leading, well-matched technologies.
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 compliance with Good Laboratory Practice (GLP) standards in qPCR, dPCR, and molecular biology. We are Good Clinical Laboratory Practice (GCLP) compliant and ISO/IEC 17025 certified.
Assay validation
Accelerate drug development with validated assays
Development, validation, and analysis of custom PCR assays for pharmacokinetics (PK), biodistribution, and viral shedding.
Our assay validation covers extraction, RT-PCR, and qPCR or dPCR analysis to meet regulatory authorities’ accuracy and precision standards. Our assays detect and quantify rare targets such as cfDNA, viral vector DNA, transgene-expressed mRNA, siRNA, and other drug products and genetic and expressional biomarkers. A validated assay ensures reliable performance throughout the entire drug development program.
A validated assay is a valuable asset
PCR technologies, such as quantitative PCR (qPCR) and particularly digital PCR (dPCR), are critical tools for AAV shedding assays. They offer the high sensitivity and specificity essential for assessing viral load across various sample types. Open application note in PFD
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 risk of transmission to a third party is mitigated.
Biodistribution assays conducted in accordance with ICH S12 guidelines. Biodistribution aims to understand the distribution of therapeutic genetic material in various target and non-target tissues in cell and gene therapies. This data is crucial for correlating with mRNA expression data
About us
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.
Regulated laboratory environment
We are GLP accredited for qPCR, dPCR, and molecular biology, GCLP compliant, and ISO/IEC 17025 accredited. Our facility features a strict sample management process, a fully integrated LIMS system, backup for all vital systems, temperature and humidity control, and robust IT security.
Purpose-built PCR laboratory
Our purpose-built laboratory in Gothenburg, Sweden, is specifically designed for PCR. It has controlled air pressure, temporal separation, and biosafety cabinets to minimize contamination risk. This setup enables us to achieve the highest sensitivity and robustness required for validated assays. The lab is equipped with market-leading PCR and NGS instruments and advanced liquid handling systems.
Pioneers in assay development and validation
We are a team of 45 employees, with scientists at the forefront of assay development, optimization, and validation. Our team has co-authored key publications in the field, including Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development (AAPS J. 2024) and The MIQE Guidelines for qPCR and dPCR.
Flexible, client-centered solutions
We work closely with our clients to find tailored solutions, offering flexibility in sample types, test items, sample volume, and scalability. We prioritize transparency and proactive communication throughout each project, ensuring our clients are continuously updated on the progress.
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Let's explore how we can support your drug development program
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