Shedding at TATAA Biocenter
Advancing PCR bioanalysis

Shedding of gene therapy products

At TATAA Biocenter, we collaborate closely with you to custom-design assays that accurately detect your shed products in excreta, secreta, or skin swabs. Our highly sensitive assays are validated to be in line with regulatory requirements.

Shedding guided by FDA and EMA

Preclinical and clinical shedding

Digital PCR (dPCR) outperforms quantitative PCR for shedding. We develop, optimize, and validate highly sensitive dPCR assays for shedding assessments. The assay sensitivity is critical when dealing with shed nucleic acids from replication-incompetent viral vectors, often present in very low copy numbers. The matrices in which these nucleic acids are found pose additional challenges, including DNA-degrading enzymes, PCR-inhibitory substances, and high levels of genetic background from endogenous flora and environmental microorganisms. We routinely overcome these challenges.

Shedding instruments
Shedding FDA

Recommendations and analysis of shedding studies by FDA and EMA

At TATAA Biocenter, we adhere to FDA and EMA guidelines, which mandate the study of preclinical and clinical shedding to mitigate the risk of transmission to untreated individuals. Our assays are designed to offer the sensitivity needed to detect shedding across various matrices, such as excreta, secreta, or the skin. The selection of these matrices is based on the nature of the product, its tropism, and the route of administration.


Immunological considerations

Pre-existing immunity, or immune priming during repeated administrations, can significantly affect drug efficacy, necessitating immunity testing to ensure reliable data. Using only microliters of plasma or blood samples, we use Olink Target 48 Cytokine panels to monitor the activation of the innate immune response through absolute quantification of key cytokines.

Viral shedding assays presents unique challenges. The analytes released are typically found in very low quantities, and the matrices involved in shedding assays often contain significant levels of PCR inhibitory agents and endogenous DNA. Our shedding services The FDA requires

Recommendation and analysis of shedding studies by the FDA Shedding assays require optimized extraction protocols tailored for each sample type and an accurate qPCR/dPCR assay with the necessary sensitivity and specificity. This ensures that shed products are detected and the

The Olink Target 96 panels are designed for high throughput, cost efficiency, and low sample consumption, facilitating targeted biomarker research in various disease areas and biological processes. Explore Our Olink Services The Olink Target 96 panels simultaneously enable high-multiplex targeting


Let's explore how we can support your drug development program.

PK/PD​ bioanalysis

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