European Medicines Agency (EMA) has cleared Roche's cancer drug MabThera after concluding that contamination at API bioreactors possess little threat.
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MabThera, also known as Rituxan, was declared safe to use, following a contamination scare at Roche’s facility in Vacaville, California, US.
MabThera is used to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia, as well as rheumatoid arthritis.
The Leptospira licerasiae bacteria, which causes leptospirosis, was detected at an early stage of the manufacturing process in bioreactors at the facility and was not found at later stages.
The Agency confirmed that all material in which the bacteria had been detected was discarded.
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