Molecular analysis CRO

Need a shedding assay for your CGT product?

We specialize in conducting studies to test for viral shedding. As a Contract Research Organization (CRO), we offer specialized services utilizing qPCR and dPCR for comprehensive bioanalysis, including assessments for shedding and vector detection.

Assay development, optimization, qualification and validation

EXTRACTION

Shedding assays presents unique challenges. The analytes released are typically found in very low quantities, and the objective may be to detect even absence. Additionally, the matrices for shedding assays often contain significant levels of PCR inhibitory agents and endogenous DNA.

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

We typically employ dPCR assays for shedding analyses due to their superior detection capabilities compared to qPCR, as they exhibit lower detection limits and are less susceptible to inhibition. Our primary focus is on detecting the vector, with less emphasis on the transgene sequence itself.

ANALYSIS

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.