Genentech taken to task over Avastin production
pharmafile | May 15, 2012 | News story | Manufacturing and Production |Â Â Genentech, Phil Taylor, avastin, manufacturingÂ
FDA inspections of a manufacturing facility for Roche/Genentech’s cancer drug Avastin (bevacizumab) uncovered a number of deficiencies which could increase the risk of contamination, according to a report posted recently on the agency’s website.
The inspections of the South San Francisco facility in California, US were carried out in September 2011 and included repeat violations uncovered in an earlier inspection, according to the report.
Among the deviations from current Good Manufacturing Practice (cGMP) uncovered at the plant were failure to generate written records of investigations into batch failures because of out-of-specification (OOS) test results – an increasingly common complaint raised by FDA inspectors.
Specifically, Genentech did not properly record whether a case of particulate contamination – thought to be caused by disintegrating gaskets on a vial washer – had been properly investigated, which was a repeat of an earlier offence.
There was also no record of whether a batch of vials affected by an oil leak had been discarded, or indeed if the leak was repaired before manufacturing resumed.
The inspection also found that some of the equipment used in the Avastin production process was not of appropriate design to facilitate operations for its intended use, because it could allow non-filtered air to pass over vials during capping, potentially allowing contamination to occur.
Genentech had also failed to reliably handle and store closures in a way that would prevent contamination, while procedures designed to prevent microbiological contamination of supposedly sterile drug product were not followed.
In an emailed statement, Genentech said it had responded to each observation raised by the FDA and believed its responses were “thorough and complete and confirm that our operations continue to comply with cGMP standards”.
“We do not have any current manufacturing issues with Avastin,” asserted the company.
The South San Francisco facility was the first to be set up by company and has been in operation since the mid-1980s, accounting for the bulk of the firm’s production capacity. Avastin is also made at Genentech’s two other plants in Vacaville and Oceanside.
Phil Taylor
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