Detecting viral and transgene genetic material
A CRO specializing in cell and gene therapy bioanalysis
We specialize in cell and gene therapy bioanalysis, developing and validating highly sensitive quantitative assays for the extraction and analysis of unique test items related to biodistribution and shedding. We also perform biomarker and immune response analyses.
Comprehensive support for the development of cell and gene therapies
Biodistribution
We design and validate tailored assays for biodistribution studies of vector DNA, siRNA, messenger RNA, or other edited gene targets in non-target and target tissues. Our approach ensures precise tracking and analysis, which is critical for understanding gene therapies’ distribution patterns and efficacy.
Shedding
We design and conduct assays to monitor shedding events in preclinical and clinical samples. Our methods are aligned with regulatory requirements, providing reliable data that is a cornerstone for the safe development and deployment of therapeutic agents.
Immune response activation
We provide advanced immunoprofiling and immune response monitoring services to support the development of cell and gene therapies. We deliver in-depth insights into the immune system’s response using qPCR/dPCR, NGS, and Olink proteomics.
Biomarker profiling
We offer comprehensive biomarker services to support the development of cell and gene therapies (CGT). Our expertise includes gene expression analysis using NGS and qPCR/dPCR, TCR/BCR sequencing, and Olink proteomics, delivering precise, actionable data for biomarker discovery and validation.
PK
We conduct pharmacokinetics using qPCR or dPCR to track levels of nucleic acids or gene therapies, such as siRNA, mRNA, viral vectors, and other DNA/RNA-based therapeutics.
Manufacturing quality assessments
Accelerate optimization, production, and decision-making with our PCR services. We provide non-GMP data from validated assays with faster lead times than most GMP laboratories, ideal for quicker analysis or when GMP compliance is not required.
Stay in touch
Sign up for our newsletter
test
"*" indicates required fields
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.
method validation
Accelerate drug development with validated assays
Assay validation ensures consistent and reliable performance, even with expected variations in conditions. We thoroughly validate each matrix, test item, and PCR assay, ensuring the entire workflow meets the required criteria, from extraction to sample analysis. The validation level is tailored to the specific context of use.
A validated assay is a valuable asset.
Extraction
Accurate quantification begins with precise extraction
Comprehensive extraction across all sample types and test items
We have extensive experience extracting nucleic acids from various biological samples, including tissues, biofluids, swabs, excreta, secreta, fresh frozen, or FFPE-fixed.
Our expertise covers the extraction of different types of nucleic acids, including DNA, cfDNA, short RNAs (miRNA, siRNA, and more), messenger RNA, and ASOs with diverse modifications and chemical properties.
We consistently include spike-ins to ensure efficient extraction, optimal quality for downstream applications, and the removal of inhibitory agents. Our goal is the accurate quantification of the target molecule, where precise, high-quality extraction is essential for achieving both accuracy and precision.
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.
contact us
Let's explore how we can support your drug development program
One form for all pages, including link to mailchimp.
"*" indicates required fields
