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Mikael Kubista, CEO, and Maria Flärdh, QA manager, in the new TATAA Biocenter GLP facility in Gothenburg, Sweden.
Mikael Kubista, CEO, and Maria Flärdh, QA manager, in the new TATAA Biocenter GLP facility in Gothenburg, Sweden.

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TATAA Biocenter Announces the Opening of New GLP Compliant Laboratory in Gothenburg, Sweden

TATAA Biocenter, an industry-leading nucleic acid analysis services provider, is excited to announce the opening of a Good Laboratory Practice (GLP) compliant facility in Gothenburg, Sweden. The new facility, which is set to open on December 3rd, 2021, will specialize in quality control (QC) analytics to better support the needs of gene and cell therapeutics.

By specializing in QC analytics, TATAA is hoping to address unmet needs within nucleic acid-based drugs, especially within gene and cell therapies, where impurities in the product could pose significant risk and danger to patients’ lives. Unlike traditional contract research organizations and established laboratories, TATAA differentiates itself by offering new methods that meet the sensitivity requirements necessary for robust molecular analyses for these projects. TATAA’s new 2,000-square-meter facility is customized to minimize contamination and optimize their laboratory workflow.

“We’re offering innovative methods for quality control of gene and cell therapeutics, and these are based on qPCR, digital PCR and next-generation sequencing. We’re the first lab with this focus, which is our core competence since 20 years,” says Mikael Kubista, Ph.D., CEO and Founder of the TATAA Biocenter.

The new GLP facility complements TATAA’s existing ISO 17025:2018 accreditation. TATAA will continue to design and validate custom assays for their customers and are excited to enhance their existing services by tracing samples throughout the analytical process. TATAA also provides routine product testing, courses, and contamination-prevention consulting.

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TATAA Biocenter is leading provider of molecular service as center to the Advanced Therapies and Medical products (ATMP) industry in Europe and the Cell and Gene Therapy in the United States. With ISO 17025 accreditation and Good Laboratory and Clinical Practices (GLP/GCP) TATAA is perfectly positioned to support the pharmaceutical industry with biomarker profiling including genomics, transcriptomics, proteomics and microbiomics with traditional qPCR, dPCR and NGS methods as well as proprietary methods such as Two-Tailed PCR and Direct Blood Genotyping.

Presskontakt

Mikael Kubista

Mikael Kubista

Presskontakt CEO Cell and Gene Therapy +46733928168
Romina Cifliku

Romina Cifliku

Presskontakt Project Manager +46 728815843

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TATAA BIOCENTER - EUROPE'S LEADING PROVIDER OF MOLECULAR SERVICES

TATAA Biocenter was started as center of excellence in Gothenburg, Sweden in 2001 by Dr Kubista and coworkers who were pioneers developing the qPCR field and in 1995 invented the light-up probes. Today TATAA Biocenter is the largest provider of qPCR training globally, and Europe´s leading provider of molecular services with ISO 17025 accreditation. In 2019 TATAA was named “Best Nucleic Acid Analysis Service provider – Europe” by Global Health & Pharma. Currently, TATAA Biocenter is undergoing major expansion implementing GLP/GCP compliant services and expanding into the Unites States. Kubista co-authored the MIQE and dMIQE guidelines for qPCR and dPCR analyses and he is member of the CEN/ISO working group developing guidelines for molecular diagnostics. Most recently TATAA invented Two-tailed PCR for the analysis of short nucleic acids and Direct Blood Genotyping.

TATAA Biocenter AB
Sofierogatan 3A
412 51 Göteborg
Sverige