Genentech’s Experience with Rituxin Process Bacterial Contamination Reveals Biotech Industry Vulnerabilities and Defense Strategies

Genentech has been sharing its experience with a novel and difficult-to-detect bacterial contamination in its rituximab cell culture process in the effort to advance the related detection and control science and help arm industry against its recurrence.

A presentation given by Genentech Late-Stage Cell Culture Pharmaceutical Technical Development Director Robert Kiss at an ISPE conference on “redefining the C in CGMP” in early June, in Baltimore, Maryland represents the third time that Genentech has shared the information in a public forum this spring.

Genentech Quality VP Anders Vinther, who is currently serving as PDA board chairman, gave the first presentation at the PDA annual meeting in Phoenix, Arizona in mid-April (Vinther’s full remarks are provided below).  Kiss then addressed the contamination at a cell culture engineering conference a few weeks later.

At the ISPE meeting, Kiss emphasized that “sharing this knowledge and the lessons learned is not only important for the industry, but for patients…and for ensuring quality products, the supply of quality products, and continually improving our processes.”

Genentech’s contamination involved the bacterium Leptospira, which is not detected by Gram stain or standard bioburden testing, does not cause a change in pH or dissolved oxygen in a bioreactor as do most cell culture contaminants, and can pass through a 0.1 micron filter.

“Because of the nature of the issue,” Kiss explained, “we felt it was really important to share this story with the industry and with regulators.”

Vinther drew a parallel between Genentech sharing its Leptospira contamination experience to the sharing that has been going on in the viral contamination context (IPQ “The News in Depth” February 8. 2012).

Although a contamination happens rarely, he commented, “when it happens, I think we have the obligation to share with each other, because we all want to have the best control mechanisms so that the products we are producing for our patients are safe.”

Rituximab is the active ingredient in Rituxin (called MabThera in Europe), a medicine used to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia as well as rheumatoid arthritis. Cleared by FDA in 1997, it was the first recombinant antibody approved for the treatment of cancer.

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