Genentech fixes problems that earned US Herceptin plant a Form 483

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Genentech has resolved the issues that earned its Herceptin API plant in Vacaville, California a Form 483 from the US FDA last year.

The US regulatory agency issued the biotech firm with the 483 on September 6 after an investigation in August revealed that conditions in the sites drug ingredient weighing and dispensing areas were not up to code and that the plant's water system had leaks.

According to the form Food and Drug Administration (FDA) inspectors Henry Lan, Lance De Souza, and Robert Tollefsen also criticised Genentech for not finding out why several of the cell banks that store the mammalian cells used in production had thawed out.

Silvia Dobry, a communications officer for Genentech’s owner Roche, told the firm has resolved all the problems and invested in systems to prevent any recurrence.

We responded to each observation raised by the FDA in a response letter shortly after receiving the 483.We have addressed all of the observations in a comprehensive manner, and have communicated our actions to FDA.    

We continue drug substance manufacturing operations at our Vacaville facility with no disruption to supply. We have made sure all of the facility and equipment, including those items pointed out by the FDA, is suitable for use in our cGMP facilities.”

Dobry added that: “Our program includes necessary cleaning, maintenance and investments where necessary. We have accounted for the FDA's observations going forward.

Expansion plan

The new investments – details of which were not provided – are in addition to the CHF140m ($153m) that Roche committed to spend on expanding production capacity at the facility to 240,000 litres in November.

Expansion of the Vacaville site – where Genentech also makes Rituxan, Avastin, Perjeta and Xolair – was driven by an unexpected surge in demand according to Genentech spokesperson Robin Snyder who spoke with this publication last year.

The anticipated product erosion from competitor’s biosimilar products has not occurred and instead we have experienced increasing demand.”

In the months since the investment was announced the level of market competition for one of the drugs – Herceptin – has changed.

Biocon and Mylan gained approval for their rival product in India in December and – earlier this week - Celltrion was cleared to sell a version of the monoclonal antibody drug in South Korea.

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