Custom-designed assays with high sensitivity

Molecular analysis CRO

We advance PCR bioanalysis and biomarker profiling by developing tailored, highly sensitive assays for biodistribution, viral shedding, and expression analysis in nucleic acid therapy drug development.

Cell and gene therapy experts

Detection of viral and transgene RNA and DNA analytes

With decades of expertise in nucleic acid extraction, assay design, and optimization of PCR and NGS-based methods, we can extract, detect, and quantify trace amounts of nucleic acid targets within complex matrices. Our bioanalysis services analyze the distribution, persistence, and clearance of foreign nucleic acids and genetically modified cells with customized projects for each sponsor.

Molecular analysis for cell and gene therapies

We specialize in cell and gene therapy bioanalysis, including assay design and validation for biodistribution, shedding, and immunoprofiling. We optimize the extraction of your test item(s) from any biological matrix, validate the assay in accordance with regulatory requirements, and set performance criteria. We also run PCR-based bioanalysis on short nucleic acids such as siRNA, miRNA, and ASOs using Two-Tailed PCR technology. 

Biomarker profiling

Our gene expression services include extraction validation from any biological sample, whether fresh or FFPE. We offer targeted assay design for your specific messenger RNA or transcriptomics focusing on specific pathways or disease areas. We design assays for small non-coding RNAs using Two-Tailed PCR technology. For immune system inquiries, we utilize Olink’s immunoprofiling panels. We use Olink’s Explore protein panels, or NGS approaches such as whole genome sequencing, whole exome sequencing, or transcriptomics for biomarker discovery.

Molecular analyses in drug development

Support at every phase for well-informed decisions

We accelerate time-to-market with rapid and reliable data, enabling informed stage-gate decisions and preparing submission-ready reports. We excel at identifying and monitoring nucleic acid biomarkers essential for understanding target engagement, efficacy, potency, and safety of cell, gene, and RNA therapies.

ATMP
Discovery

In early discovery, we identify valuable biomarkers for candidate selection, lead optimization, and patient stratification. In addition, we run quantitative analyses to provide the necessary data for vector evaluation and optimization, including tissue specificity and potency for lead candidate selection.

Preclinical

We offer a spectrum of assay validation for regulatory filings and confident decision-making, ranging from fully validated assays to fit-for-purpose assays for various bioanalyses, including PK/PD, biodistribution, and viral shedding.

Clinical

With a state-of-the-art instrumentation fleet, automated platforms, and an integrated Laboratory Information Management System (LIMS), we conduct high-throughput analysis of clinical nucleic acid biomarkers for patient stratification, efficacy, and safety endpoint.

ATMP
Discovery

In early discovery, we identify valuable biomarkers for candidate selection, lead optimization, and patient stratification. In addition, we run quantitative analyses to provide the necessary data for vector evaluation and optimization, including tissue specificity and potency for lead candidate selection.

Preclinical

We offer a spectrum of assay validation for regulatory filings and confident decision-making, ranging from fully validated assays to fit-for-purpose assays for covering various bioanalyses, including PK/PD, biodistribution, and viral shedding.

Clinical

We use the highest quality reagents, adhere to dedicated controls, standardize and harmonize all processes per technical requirements like the MIQE guidelines. We deliver rapid, robust and reproducible results that are submission-ready.

applications

Solutions for complex biological challenges

We offer a comprehensive range of tailored services for drug development programs. With over two decades of expertise in nucleic acid analysis and sample preparation, we excel in sample extraction and quality assessment, method development and validation, and analyzing biomarkers using leading, well-matched technologies.

Services

Solutions for complex biological challenges

We specialize in nucleic acid therapy drug development and bioanalysis, extracting and detecting your test item in biological samples with the necessary performance requirements, whether regulated or non-regulated. Additionally, we perform biomarker profiling on small non-coding RNAs, messenger RNA, genome, and protein.