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5 articles
When an antibody supplier, expression system or conjugation process changes, the assay does not simply carry on. UK IVD developers need a structured bridging file that connects comparability data to assay performance and UKCA evidence. This checklist sets out what a defensible handover should contain in 2026.
UKCA marking is not a single hurdle but a sequence of evidence, registration and labelling decisions. This guide sets out where CE marking still carries weight in Great Britain, the documentation points that most often stall small diagnostic developers, and a practical checklist for planning submissions in 2026.
Antibody performance is often treated as a property of the vial, but it is also a property of the conditions under which the vial is kept. This article sets out a proportionate storage audit for UK laboratories—covering temperature records, freeze–thaw history, glycerol concentration and freezer resilience—that can stand up to grant review, quality scrutiny and supplier discussion.
UK diagnostic developers are taking a fresh look at polyclonal antibodies for lateral flow, not as a legacy ascites product but as a practical option for complex matrices and supply resilience. This review sets out the technical and regulatory criteria that should guide selection in 2026.
Recombinant antibodies are no longer a niche alternative, but the shift from hybridoma-derived reagents is not automatic. This analysis examines what the change means for UK startups, NHS diagnostic suppliers and academic core facilities, and sets out the commercial, IP and regulatory questions that should be asked early.