We understand the critical role our products play in supporting healthcare providers and diagnostic laboratories. As we transition to the new IVDR standards, we are dedicated to maintaining uninterrupted service while aligning with these regulations. By prioritizing the transition process, we will ... Read more
The In Vitro Diagnostic Regulation (IVDR) represents a significant milestone in the regulation of diagnostic tests within the European Union. This regulation aims to ensure that diagnostic tests available in the European market are safe, effective, and reliable. IVDR addresses previous gaps in the ... Read more
In gene therapy, immunogenicity isn't just a hurdle, it's a make-or-break factor! Whether you are in the early or late stages of development, reliable data specific to your vector is essential to ensure relevance in your vector’s safety profile assessment. Assessing the presence of anti-AAV ... Read more
In AAV gene therapy, safety isn't optional-it's everything. That's why we're proud to introduce a powerful new tool to your immunogenicity toolkit: the AAV Complement Activation Assay. This assay is the first of its kind available on the market, giving you a critical edge in detecting and managing ... Read more