ASSAY DEVELOPMENT AND ANALYSIS
Quality assessments for cell and gene therapies
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.
QUALITY ANALYSES
Fast and reliable results
Our rapid data delivery enables accelerated process optimizations and instills confidence before testing the batch in a GMP facility. PCR provides immediate results, making it well-suited for assessing viable products, crucial for cell and gene therapies.
Vector copy number
Quantifying the transgene dosage, the presence of transgenes, the number of integrated vectors, or the number of non-integrated vector genomes in targeted cells provides essential information during production optimization.
Host cell DNA residuals
We use PCR approaches to detect DNA impurities, including E1A, from host production cells or plasmids used for transfection in gene therapy viral vector production.
Vector integrity
Based on your specifications, we characterize the packaged vector genome to compare results across batches and instill confidence in your clinical formulations
Pathogen detection
We use sequencing techniques to test for sterility, mycoplasma, and endotoxins for rapid results.
Integration site analysis
We evaluate the integration site specificity, transduction efficiency, and detect unintended effects on adjacent gene expression during integration.
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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.
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Let's explore how we can support your drug development program
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