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As industries evolve, so do regulations governing them. The In Vitro Diagnostic Regulation (IVDR) was introduced to enhance the safety and efficacy of in vitro diagnostic medical devices (IVDs) within the European Union (EU). While its primary focus is on IVDs, the ripple effect of IVDR extends beyond its intended scope, creeping into regulated bioanalysis. This article explores the unforeseen consequences of scope creep from IVDR into regulated bioanalysis and how stakeholde

In the realm of modern medicine, diagnostic tests play a pivotal role in identifying and treating diseases. As technology advances, so too does our ability to develop increasingly sophisticated tests that can provide valuable insights into a patient's health. Among these are Laboratory Developed Tests (LDTs), which are designed, manufactured, and used within a single laboratory. On April 29th, 2024, the FDA made a significant announcement regarding the regulation of these tes

Fleet will be attending the London Biotechnology Show, taking place 8th and 9th May at Olympia. The London Biotechnology Show aims to be a premier biotechnology event in the UK and the broader European region to expedite the progress of biotechnology for revolutionising medical & healthcare sectors globally. The event will host a world-class exhibition and a comprehensive conference that will bring together leading policymakers, thought leaders, investors, industry experts, s

This article explores the challenges in developing ADA assays for immunogenicity studies, including sensitivity, drug tolerance, cross-reactivity, and assay interference.

Fleet Bioprocessing has successfully been re-certified as meeting the standards of Cyber Essentials. Cyber Essentials is a Government backed scheme designed by the National Cyber Security Centre. By meeting the standards of Cyber Essentials, an organisation demonstrates that the defenses and controls in place will effectively protect against the vast majority of common cyber attacks.

This article explores ADA assay platforms for immunogenicity studies, comparing ELISA, ECL, SPR, multiplex assays and Gyrolab to support platform selection and reliable assay performance