Custom-designed molecular bioanalytical services
GLP- and GCLP-compliant bioanalysis and biomarker analysis services.
Custom regulated assays
Design, optimization, qualification, validation, and high-throughput analysis.
Cell and gene therapy services
Advanced therapies, such as gene therapies, RNA therapeutics, and RNA vaccines, require custom-developed and validated methods with high precision and sensitivity to accurately quantify low-copy-number viral vectors, transgene expression, and modified therapeutic nucleic acid drugs during drug development. As a leading CRO, we specialize in bioanalysis for ASOs, CRISPR, siRNA, mRNA, and other advanced modalities.
We accelerate your drug development program with expertise, experience, and a market-leading compliant laboratory.
Gene therapy analytes and biomarkers
Analyzed using qPCR, dPCR, NGS, and affinity-based proteomics
- AAV vectors (encapsidated, in LNPs, or as free DNA)
- Lentiviral and retroviral vectors
- mRNA
- miRNA, siRNA, gRNA
- ctDNA, MRD, SNPs
- Cytokines
- Plasma proteins and pQTL
We perform GLP and GCLP compliant bioanalysis and biomarker analysis of RNA, DNA, and proteins in blood, tissues and other biofluids for gene therapies, RNA therapeutics, RNA vaccines, and other advanced therapies.
Biomarker analysis CRO
Biomarker assay and analysis services for proteomic and genomic biomarkers across all phases of drug development. We analyze gene expression changes, protein expression changes, and pharmacogenomic biomarkers for discovery, validation, and sample analysis in preclinical and clinical trials.
GLP and GCLP compliant laboratory
We are accredited for Good Laboratory Practice (GLP) by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) for qPCR, dPCR, and molecular biology. We are also Good Clinical Laboratory Practice (GCLP) compliant to ensure the safe and reliable analysis of clinical samples.
A purpose-built, pressure-controlled laboratory designed to maximize assay sensitivity
Compliance and quality assurance
- Fully integrated and validated LIMS
- Robust QMS
- Backups for vital systems (data storage, electricity, and instruments)
- Controlled temperature and humidity
- Comprehensive SOPs
- Skilled and qualified personnel
- Regular audits
- Transparent communication
- IT security for data integrity and protection
Instrumentation and automation
- Market-leading qPCR, dPCR, and NGS platforms.
- Automated liquid handling systems for standardized and reproducible workflows.
Resources
Overview of bioanalysis in advanced therapies
- Assay design and validation
- Regulatory guidelines (EMA and FDA)
- Challenges and best practices
Genomic biomarker analysis (DNA, RNA, miRNA, ctDNA etc,)
- Technology overview
- Analytical validation
- Regulatory overview
Capability PDF
Download our latest brochure for a summary of our molecular CRO services and capabilities.