PCR and NGS services
Bioanalytical CRO for cell and gene therapies
Our bioanalytical services include qPCR and dPCR for biomarker profiling and bioanalysis assays for CTG, precision medicine, and ATMPs.
Bioanalytics services
Quantification of viral and transgene RNA and DNA
We offer comprehensive bioanalysis services, including extracting, detecting, and quantifying viral and transgene RNA and DNA analytes from diverse tissues and biofluids. We design and conduct assays, ensuring that the validation aligns with your regulatory requirements, whether for fit-for-purpose or full validation.
PK/PD
PK/PD analytes, including vector DNA, transgene DNA, or transgene RNA, are extracted and quantified using validated PCR methods to determine the PK and PD profiles.
Biodistribution
We monitor the biodistribution of genetically modified cells, viral vectors, and mRNA vaccines within the body using validated PCR methods.
Shedding
We quantify shed viruses, bacteria-based gene therapy products, or oncolytic products in sweat, urine, excreta, and various body fluids.
Transgene Expression
We quantify transgene RNA, derived from foreign genetic material, as a surrogate marker for protein expression and correlate it with bioanalysis for dosage optimization.
Assay development, optimization, qualification and validation
EXTRACTION
Extraction of siRNA, miRNA, viral vectors, and DNA from various tissues, biofluids, and excreta, ensuring the required purity for downstream applications.
ASSAY VALIDATION
Depending on regulatory requirements, we conduct fit-for-purpose validations for early discovery and more comprehensive method validation processes for preclinical and clinical assays.
ASSAY DEVELOPMENT
At our bioanalytical CRO, we specialize in developing custom qPCR and dPCR assays capable of detecting nucleic acid analytes with high specificity and sensitivity, whether in single or multiplexed formats.
MOLECULAR SERVICES
Our state-of-the-art PCR facilities feature controlled air pressure, strategic workflows, and segregated areas to minimize contamination risks. With advanced instrumentation, automation, and LIMS support, we offer the optimal technology for your program.
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