TATAA Biocenter

TATAA Biocenter is a leading molecular CRO providing customized, high-precision bioanalytical services for drug development from preclinical research through clinical trials. The company specializes in advanced therapies including gene therapy, cell therapy, and RNA therapeutics.

Core Services

• Bioanalysis & Biomarkers: Biomarker discovery, assay design and validation, and biomarker analysis services compliant with FDA and EMA regulatory expectations
• Molecular Analysis: qPCR, dPCR, next-generation sequencing (NGS), and affinity-based proteomics (Olink)
• Specialized Assays: Biodistribution, shedding, pharmacokinetics, pharmacodynamics, gene expression analysis, pharmacogenomics, plasma protein biomarker analysis, immune monitoring, and vector copy number quantification
• Sample Analysis: RNA and DNA extraction, RNA-Seq, DNA-Seq, TCR sequencing, BCR sequencing, and Illumina protein prep

Regulatory & Quality

GLP-accredited by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) for qPCR, dPCR, and molecular biology. GCLP-compliant for clinical sample analysis. ISO/IEC 17025-compliant. The company operates a purpose-built laboratory with dedicated clean areas, separate pre- and post-PCR zones, automated liquid handling systems, and a comprehensive digital laboratory ecosystem (LIMS and ELN).

Expertise & Leadership

With 25 years of experience providing qPCR services since 2001, TATAA Biocenter has contributed to hundreds of validated assays and published works, including co-authorship of the MIQE guidelines and bioanalysis guidelines. The team comprises 40 scientists, including more than 30 PhDs and Master's-level scientists. The company is recognized as a pioneer in cell and gene therapy bioanalysis, shaping standards in a field with limited regulatory guidance.