From 4 to 7 June 2024, a technical training session for official medicines control laboratories (OMCLs) on cell-based bioassay testing took place on the premises of FIMEA in Helsinki, where the Finnish OMCL is located. This was the second cell-based bioassay training, the first being held in Lisbon, Portugal, in April 2023. All OMCL hands-on programmes are co-organised by members of the General European OMCL Network (GEON) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The objective of the four-day training in Helsinki was to run through all the steps of a cell-based bioassay on a selected monoclonal antibody. The ultimate goal of this training programme is to increase the pool of specialised OMCLs competent in running this technique, not only for the testing of medicines suspected of being falsified, but also for routine market surveillance purposes. The test design was as follows:

• Test principle: Cell-based assays for potency determination of TNF-alpha antagonists - WEHI-164 Cytotoxicity assay
• Cell line: WEHI-164 (ATCC CRL-1751)
• Read out: UV absorbance

Eight OMCL representatives from eight European countries attended the course, which consisted of a mixture of theoretical lectures and practical sessions in four small groups. This allowed for an intensive exchange of know-how between laboratory experts and discussions on technical details regarding the handling of biologicals in laboratories, and on evaluating and interpreting results of the tests.

Additional training programmes on this topic are in the pipeline.

Hands-on training for OMCLs has become a regular offer of the GEON. This format is seen as an important contribution to broadening the fields of activities of OMCLs in independent market surveillance testing of legal and falsified medicines.

More information about previous Technical OMCL Falsified Medicines Training