Bioanalytical CRO
AAV analytical services
We are a molecular CRO specializing in AAV bioanalysis. We develop, validate, and perform custom extraction and qPCR/dPCR assays for biodistribution, shedding, and biomarker analysis.
Molecular bioanalytical services
Validated assays for AAV bioanalysis
We develop, optimize, and validate PCR assays tailored to your target and biological sample, ensuring extraction performance, PCR sensitivity, accuracy, and robustness to support regulatory submissions.
Pharmacokinetics (PK)
PK studies for AAV-based gene therapies address blood and tissue biodistribution. The primary analytes include AAV DNA, transgene DNA, and the transcribed RNA species (mRNA, siRNA, and miRNA).
Biodistribution
We measure vector DNA, transgene DNA, and transcribed RNA in blood, injection site(s), kidney, liver, heart, lung, spleen, brain, spinal cord (cervical, thoracic, and lumbar), gonads, adrenal glands, and other samples of choice.
Shedding
We measure capsulated and non-capsulated AAV DNA with high sensitivity in excreta (e.g., feces), secreta (e.g., urine, saliva, nasopharyngeal fluids), and through the skin (e.g., pustules, sores, or wounds), as well as other sample types.
Pharmacodynamics (PD)
We use affinity-based proteomic approaches and NGS to analyze expressional changes and discover PD biomarkers correlating with transgene-transcribed RNA. Additionally, we conduct biomarker validation studies and targeted PCR assays for single or multiple PD biomarkers.
Immunogenicity
We evaluate pre-existing and post-infusion immunogenicity using Olink’s Cytokine and Inflammation panels, as well as TCR/BCR sequencing, to track the expansion of transgene-specific T-cell clones and B-cell clones responsible for producing anti-transgene or anti-vector antibodies.
Genotoxicity
We identify integration sites and genetic modifications using NGS to monitor genotoxicity and off-target effects during preclinical and clinical trials.
Manufacturing quality assessments
We accelerate production and optimization by providing rapid analysis of host cell DNA residuals, vector copy numbers, and integrity. We ensure informed decision-making and expediting project timelines.
TWO-Tailed PCR technology
Short RNA with qPCR/dPCR
A TATAA Biocenter innovation that offers validated qPCR/dPCR workflows for siRNA, miRNA, ASOs, and other short nucleic acid targets.
PCR bioanalysis offers several advantages over other methods in speed and throughput; however, standard PCR is unsuitable for short targets due to its length. We have developed a two-tailed primer that enables the optimization, validation, and execution of PCR-based bioanalysis on any short target with high sensitivity and specificity.
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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.
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.
Quantitative PCR (qPCR), digital PCR (dPCR), and Next-Generation Sequencing (NGS) are essential technologies in siRNA bioanalysis. They provide the precise quantification, sensitivity, and specificity needed to track siRNA’s therapeutic efficacy, stability, and biodistribution. Application note: siRNA assays in bioanalysis (PDF)
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
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