EMA okays MabThera after contamination at Roche site

By Nick Taylor

- Last updated on GMT

EMA okays MabThera after contamination at Roche site
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.

Root cause

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.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...