A specialised training course on cell-based bioassay testing for Official Medicines Control Laboratories (OMCLs) was held at the laboratory of the Portuguese National Authority of Medicines and Health Products (Infarmed) in Lisbon from 31 March to 3 April 2025. This was the third training course on this topic: the first took place at Infarmed in April 2023 and the second in Helsinki, Finland, in June 2024. Like all OMCL hands-on programmes, it was jointly organised by a member of the General European OMCL Network (GEON) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).
The four-day programme combined theoretical lectures with a practical hands-on exercise, centred around a cell-based bioassay for a selected monoclonal antibody, thereby providing a comprehensive learning experience. The assay outline included:
- Test principle: complement-dependent cytotoxicity (CDC) assay.
- Cell line: WIL2-S (human, B-lymphoblastoid, expressing CD20).
- Read out: fluorescence.
Designed to support the OMCLs in preparing for both testing suspected falsified medicines and routine market surveillance, the training course brought together six OMCL representatives, each from six member states. Participants had the chance to gain practical experience and deepen their understanding of assay design and performance. This latest edition of the course included an extra day, during which the participants were given privileged access to one of the EDQM’s statisticians, who was on hand to provide practical support with the data analysis.
This initiative reflects the broader effort to enhance technical capabilities across the network, with hands-on training for OMCLs becoming a regular opportunity within the GEON. Additional training sessions are in the pipeline with the aim of strengthening the preparedness and expertise of more OMCLs in the testing of legal and falsified medicines.
More information about previous Technical OMCL Falsified Medicines Training