TATAA Biocenter has been awarded Good Laboratory Practice (GLP) accreditation. The accreditation supports the company’s strategic progression in the molecular analysis contract research organization space for advanced biopharmaceutical therapies and precision medicine.
 
According to the company, the demand for these services is driven by the over 2,500 cell and gene therapies being developed in the U.S. 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.
 
The addition of GLP accreditation to its existing Good Clinical Laboratory (GCLP) compliant work and ISO/IEC 17025 accreditation allows the company to support clients through all development stages and regulatory filings. TATAA operates from a laboratory purpose-built around contamination-free PCR workflows, offering method development, qualification, and validation.
 
With GLP-accredited quantitative PCR and digital PCR services, TATAA Biocenter facilitates safety and efficacy assessments for emerging cell and gene therapy regulatory applications. 
 
“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.