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.

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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.

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Biodistribution

We monitor the biodistribution of genetically modified cells, viral vectors, and mRNA vaccines within the body using validated PCR methods.

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Shedding

We quantify shed viruses, bacteria-based gene therapy products, or oncolytic products in sweat, urine, excreta, and various body fluids.

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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.

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PK/PD​ bioanalysis

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