Genentech fixes problems that earned US Herceptin plant a Form 483

(Picture credit Google Maps)

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 BioPharma-Reporter.com 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.

Related News

India set to launch first biosimilar of Roche's Herceptin

Biocon defends price of biosimilars as it launches Herceptin copycat

Recently approved Herceptin biosimilars in india face Roche injunction

Mylan: Roche's Herceptin biosimilar injunction will not stop production

(Picture credit: Flickr/TK-Link)

Foreign customers look to US FDA as stamp of quality

High Court in London acts in favour of Hospira and revokes two of Genetech's patents on Herceptin

High Court ruling against Roche paves way for EU Herceptin biosimilars

Genentech warns of fake Avastin

Genentech warns of fake Avastin

Genentech wanted $112 per share from Roche; SEC filing

FDA sends Genentech 483 after finding failings at Avastin plant

Californian governor vetoes controversial biosimilar bill

Cali Gov vetoes biosimilar bill, thwarting Amgen and Genentech

Related Products

See more related products

Submit a comment

Your comment has been saved

Post a comment

Please note that any information that you supply is protected by our Privacy and Cookie Policy. Access to all documents and request for further information are available to all users at no costs, In order to provide you with this free service, William Reed Business Media SAS does share your information with companies that have content on this site. When you access a document or request further information from this site, your information maybe shared with the owners of that document or information.