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.
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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Otilia Cheregi, PhD
Principal Investigator
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