How has the GLP accreditation changed the way you work at TATAA?
Data quality has always been a central focus for us, but achieving GLP accreditation has elevated it to a new level. It strengthens all our services, supporting not only regulated bioanalysis but also biomarker studies such as proteomics and gene expression analysis. Beyond the basics with trained staff, calibrated instruments, and optimized SOPs, GLP ensures strict sample management and traceability. All freezers, fridges, and lab humidity are monitored, IT systems securely archive raw data and instrument logs, and redundant instruments with power backups safeguard against delays or losses. These systems, often unnoticed until a failure occurs, are integral to GLP’s core purpose to minimize the risk of analysis failure.
What are the unique challenges in performing shedding and biodistribution studies for cell and gene therapies compared to small molecule drugs?
Unlike small molecules, gene therapies rely on viral vectors delivering genetic material to target organs, where it must be expressed to have an effect. The challenge is that vector DNA and transgene mRNA occur in very low amounts, requiring highly sensitive, validated methods like dPCR to quantify down to just a few copies.
Located in neighboring Gothenburg, how do you perceive the idea of increasing Danish-Swedish life science collaboration to boost European competitiveness?
By joining forces, we can create a more integrated Nordic ecosystem that not only accelerates innovation but also enhances Europe’s global competitiveness in drug development and advanced therapies. For TATAA, such collaboration means expanding opportunities to contribute with our specialized molecular bioanalysis, while building bridges that benefit patients across Europe.