Approval enables regulated analysis services for cell and gene therapies. This important milestone for TATAA Biocenter provides customers access to safety testing, accelerating the transition of promising therapies from laboratory research and preclinical testing to clinical applications.

GOTHENBURG, Sweden, April 16, 2024 /PRNewswire/ -- TATAA Biocenter announced today that it has been awarded Good Laboratory Practice (GLP) accreditation. The accreditation represents a crucial step in the company's strategic progression into a market leading molecular analysis contract research organization (CRO) expediting biopharmaceutical innovations in advanced therapies and precision medicine.

The demand for these services is driven by the over 2500 cell and gene therapies being developed in the United States and Europe and the progress of technologies involving CRISPR, AAV vectors, and mRNA therapeutics. These innovations require rigorous molecular analyses and adherence to regulated guidelines for bioanalysis and safety testing, including biodistribution, pharmacokinetics, transgene expression, and shedding throughout the developmental stages of therapies.

With the addition of GLP accreditation to its existing Good Clinical Laboratory (GCLP) compliant work and ISO/IEC 17025 accreditation, TATAA Biocenter is now positioned to support clients through all development stages and regulatory filings. TATAA operates from a laboratory purpose-built around reliable, contamination-free PCR workflows, offering clients method development, qualification, and validation.

With GLP-accredited quantitative PCR and digital PCR services, TATAA Biocenter facilitates reliable safety and efficacy assessments for emerging cell and gene therapy regulatory applications. The accreditation follows an additional investment from Care Equity, which was completed in the fall of 2023 to further empower TATAA Biocenter in its continued growth and long-term ambitions.

"As one of few laboratories with GLP accreditation for qPCR and dPCR, we can now support the pharmaceutical industry in a comprehensive way and accelerate the process through even more robust analyses, allowing therapies to reach the patient faster, " said Mathias Hallin, CEO of TATAA Biocenter.

For more information, visit www.tataa.com or contact Johanna Nilsson, Head of Marketing (johanna.nilsson@tataa.com)

About TATAA Biocenter

TATAA Biocenter specializes in providing regulated molecular analysis laboratory services for biopharmaceutical clients. Committed to quality, innovation, and fostering strong client relationships, we serve as your trusted partner to accelerate drug development. As a contract research organization, we offer clients the latest technologies and generate accurate and reproducible data that shortens time-to-market.    

TATAA's core focus is delivering high-quality, high-throughput bioanalysis for cell and gene therapies and biomarker profiling for precision medicine. Integral to the success of every study with TATAA Biocenter is the team of highly skilled scientists with extensive experience in nucleic acid analyses and knowledge of regulatory requirements.

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