FROM DISCOVERY TO APPROVED TREATMENT
GCLP, GLP and ISO/IEC 17025 laboratory
Bridging innovation with regulatory frameworks. We conduct qPCR and dPCR assays in accordance with GLP accreditation, GCLP compliance, and ISO/IEC 17025 standards.
GLP and GCLP simplify data auditing
We provide comprehensive support for drug development across all phases, holding GLP accreditation for preclinical sample analysis and complying with GCLP standards for clinical sample analysis. Accredited by SWEDAC, we adhere to rigorous requirements for qPCR and dPCR through regular external audits, ensuring our analyses’ reliability, integrity, and reproducibility, which are mandated for regulatory filings.
Our regulated services include bioanalysis assays such as PK/PD, shedding, biodistribution, and transgene expression for cell, gene, and RNA therapeutics.
GLP and GCLP
We hold GLP accreditation for qPCR and dPCR services and adhere to the GCLP guidelines, necessary for regulatory filings of pre-clinical and clinical analysis data, respectively.
ISO/IEC 17025
We are accredited for ISO/IEC 17025 for both sample preparation and downstream qPCR analysis, ensuring technical competence, reliability, and valid results.
compliant bioanalysis
Accurate and reproducible data
A GLP accredited and GCLP compliant laboratory
TATAA Biocenter is accredited by the Swedish Board of Accreditation and Conformity Assessment (SWEDAC) for complying with Good Laboratory Practice (GLP) standards. We also adhere to Good Clinical Laboratory Practice (GCLP) guidelines, which are international quality standards governing the analysis of samples from clinical trials using GLP.
GLP and GCLP ensure the reliability, consistency, and validity of data from non-clinical and clinical studies, respectively. These standards cover every aspect of study planning, execution, monitoring, documentation, archiving, and reporting. This rigorous process provides assurance to both the sponsors when submitting data for new drug approvals, and the regulatory authorities when reviewing the data, that it is generated in a regulated manner.
Assay validation
Accelerate drug development with validated assays
Development, validation, and analysis of custom PCR assays for pharmacokinetics (PK), biodistribution, and viral shedding.
Our assay validation covers extraction, RT-PCR, and qPCR or dPCR analysis to meet regulatory authorities’ accuracy and precision standards. Our assays detect and quantify rare targets such as cfDNA, viral vector DNA, transgene-expressed mRNA, siRNA, and other drug products and genetic and expressional biomarkers. A validated assay ensures reliable performance throughout the entire drug development program.
A validated assay is a valuable asset
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.
Biodistribution assays conducted in accordance with ICH S12 guidelines. Biodistribution aims to understand the distribution of therapeutic genetic material in various target and non-target tissues in cell and gene therapies. This data is crucial for correlating with mRNA expression data
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