
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.
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.
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Shedding assay design
Extraction
The extraction method must be evaluated for each matrix and test item by spiking in targets to assess recovery after sampling, handling, storage, and extraction, given that the test item may exist in very low copy numbers.
Sample management, QC, and QA
Our regulated sample management processes include a Laboratory Information Management System (LIMS) for full traceability of samples and reagents, and a purpose-built laboratory to mitigate contamination risks and ensure the highest sensitivity possible. All data undergoes 100% QC, and QA according to regulatory requirements.
Assay development
We collaborate with you to design target-specific primers and probes and validate them for their specific context of use (COU), GLP, or GCLP. We conduct tests to ensure that the PCR’s sensitivity meets the stringent requirements for shedding assays and that the matrix does not interfere with the PCR.
Collaboration, reporting, and data transfer
Our principal investigators work closely with our sponsors, ensuring transparency in the process and project progression. Throughout the assay design, we keep sponsors informed of optimization steps, viewing ourselves as your extended workbench of experts. We customize the report to align with your downstream processes.
PCR technologies, such as quantitative PCR (qPCR) and particularly digital PCR (dPCR), are critical tools for AAV shedding assays. They offer the high sensitivity and specificity essential for assessing viral load across various sample types. Open application note in PFD
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
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 risk of transmission to a third party is mitigated.
About us
The power of our approach
Committed to quality, innovation, and fostering strong client relationships, we serve as your trusted partner to accelerate drug development. As a contract research organization, our mission is to push the boundaries of science and technology to generate accurate and reproducible data that shortens time-to-market.
Regulated laboratory environment
We are GLP accredited for qPCR, dPCR, and molecular biology, GCLP compliant, and ISO/IEC 17025 accredited. Our facility features a strict sample management process, a fully integrated LIMS system, backup for all vital systems, temperature and humidity control, and robust IT security.
Purpose-built PCR laboratory
Our purpose-built laboratory in Gothenburg, Sweden, is specifically designed for PCR. It has controlled air pressure, temporal separation, and biosafety cabinets to minimize contamination risk. This setup enables us to achieve the highest sensitivity and robustness required for validated assays. The lab is equipped with market-leading PCR and NGS instruments and advanced liquid handling systems.
Pioneers in assay development and validation
We are a team of 45 employees, with scientists at the forefront of assay development, optimization, and validation. Our team has co-authored key publications in the field, including Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development (AAPS J. 2024) and The MIQE Guidelines for qPCR and dPCR.
Flexible, client-centered solutions
We work closely with our clients to find tailored solutions, offering flexibility in sample types, test items, sample volume, and scalability. We prioritize transparency and proactive communication throughout each project, ensuring our clients are continuously updated on the progress.
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