European regulators have decided that workers at a Roche ($RHHBY) plant in Vacaville, CA, probably were the source of bacteria found in a bioreactor for its MabThera drug.
The European Medicines Agency (EMA) says that no bacteria was found in late-stage processes and last week cleared the plant and drug, completing a 5-month review. It says its Committee for Medicinal Products for Human Use (CHMP) agree with the fixes Roche has made at the plant and that there are no risks to the public from the drug, which is approved in Europe for treating non-Hodgkin's lymphoma, chronic lymphocytic cancers and rheumatoid arthritis.
MabThera is one of Roche's blockbuster cancer drugs. Its patent in Europe is good for another three years, but until then the company certainly doesn't want any impediments to that cash cow.
The agency was notified by Roche in December that L. licerasiae bacteria were found in May and August in some bioreactors used to make the active ingredient of MabThera at the California plant. The was no bacteria found in later stages and all the material that had bacteria was destroyed.
CHMP inspectors went in and checked out the labs, warehouses, utility areas and manufacturing plant. It reviewed data and evaluated quality-management systems. Its determination? Workers were the likely culprits for introducing the bacteria in the reactors and its processes are sound. It is requiring Roche to develop a more sensitive test for detecting the bacteria and to submit additional data just in case.
- here are the EMA findings