Custom-designed molecular bioanalytical services
Tailored bioanalytical services for preclinical to clinical studies, focusing on oligonucleotide drugs, such as mRNA, miRNA, siRNA, ASOs, and other advanced modalities. 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.
About our bioanalytical services
qPCR & dPCR assays
We perform high-sensitivity quantitative and digital PCR for short RNAs like miRNA, siRNA, ASOs, guide RNA, and longer oligonucleotide therapeutics, delivering precise quantification for RNA drug modalities.
High-throughput sequencing (RNA‑Seq & DNA‑Seq)
Comprehensive sequencing for gene expression profiling, mutation detection, TCR/BCR repertoire analysis, and genomic biomarker discovery.
Affinity-based proteomics
Utilizes platforms like Olink® Proximity Extension Assays and Illumina protein prep, optimized for plasma proteomics, high-plex biomarker discovery, and validation.
Assay design, validation & compliance
Tailored method development and validation, with high-throughput execution from discovery through clinical phases in labs ranging from non-regulated to GLP/GCLP and ISO/IEC 17025-compliant environments.
We offer bioanalytical assays, including qPCR, dPCR, and NGS, tailored for preclinical investigations such as biodistribution, pharmacokinetics (PK), pharmacodynamics (PD), shedding, and immune monitoring.
These same workflows are fully validated and executed in GCLP- and GLP-compliant laboratories, supporting the analysis of clinical samples.
We offer short lead times for starting new bioanalytical services projects.
Thanks to our team’s extensive experience in assay development and validation, we’ve streamlined the process, making optimization and validation phases highly efficient
The typical turnaround time (TAT) for assay development varies depending on:
- Sample type
- Test item characteristics
- Required level of validation (e.g., exploratory, GLP/GCLP-compliant)
Short RNAs using Two Tailed PCR
We specialize in ultrasensitive qPCR and dPCR workflows for short miRNA, siRNA, antisense oligonucleotides (ASOs), and guide RNAs (gRNAs), enabled by our patented Two‑Tailed RT‑PCR method.
Oligonucleotide therapeutics
We quantify oligo drugs, including mRNA-based drugs, viral vectors, edited genes, CRISPR, and custom nucleic acid therapeutic using qPCR/dPCR for biodistribution, shedding, and PK analysis.
Genomic & transcriptomic biomarkers
We support RNA Seq and DNA Seq assays for:
- Gene expression profiling
- Mutation detection
- TCR/BCR repertoire analysis
- Genomic biomarker discovery
Affinity-based proteomics
Our services incorporate Olink® Proximity Extension Assays and Illumina protein prep workflows for plasma proteomics, as well as biomarker discovery and validation across protein targets.