The EMA has cleared the Roche oncology blockbuster MabThera after concluding contamination of API bioreactors poses little threat.
European Medicines Agency (EMA) okay comes one year after Roche first found Leptospira licerasiae, a potentially deadly bacterium, in bioreactors at its MabThera (rituximab) plant in California. An EMA investigation began in December and concluded patients are safe to continue using the cancer drug.
“The Committee was reassured that the findings were not associated with any clinically relevant risk for patients treated with MabThera, as no bacteria were detected in the active substance or in the finished product,” the Committee for Medicinal Products for Human Use wrote in its conclusion.
Roche detected the contaminant, which causes leptospirosis, in bioreactors used in the pre-harvest steps of rituximab production in May and again in August. This prompted the EMA to look into the problem and a Danish team visited the plant to assess its infrastructure and quality management.
The EMA concluded the benefits of MabThera outweigh the risks and recommends maintaining its marketing authorisation with certain caveats. These conditions include the development of a more sensitive test for detection of the contaminant and further data on corrective steps Roche took.
Investigators believe the contamination stems from cell culture media used in the bioreactors. The media preparation process or employees acting as carriers are two possible routes along which the contaminant may have entered the API (active pharmaceutical ingredient) production cultures.
Since finding the bacterium Roche has taken steps the EMA found adequate to cut the risk of future contamination and improve detection. Also, the lack of L licerasiae in the later stages of production suggests the manufacturing process removes the bacteria and any proteins which it releases.
Roche has discarded all material in which the bacterium was detected and will desist from further processing of any API batches produced from cultures that tested positive for the contaminant.