Xenova gets OK for UK production site
for a manufacturing facility for clinical trial materials for its
own use, as well as for its clients.
The company has joined a growing number of biotechnology companies that, following delays in their own pipelines, have turned over some manufacturing capacity to the contract sector.
Xenova has already accrued some revenues for its manufacturing activities, but approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture investigational medicinal products will help it build this side of the business.
Xenova operates a clinical trials manufacturing facility (CTMF) in Cambridge, and the new authorisation allows the conpany to manufacture IMPs in compliance with the new Clinical Trials Directive, which came into force in May of this year.
The licence was awarded after the MHRA inspected the company's premises and confirmed compliance with the EU Good Manufacturing Practices (GMP), which Xenova received in September 2003.
In the first quarter of this year, Xenova's contract manufacturing business - Xenova Biomanufacturing - brought in about £500,000 (€757,000) to its coffers, out of total revenues of around £900,000. The balance came from licensing revenues from the firm's partnered research programmes.
The CTMF is an 11,000-square-foot facility that incorporates Class 10,000 protein and virus production suites, Class 100 protein and virus filling suites, and quality control, stores, engineering, packaging and general support
Earlier this month, Xenova won a two-year contract to manufacture a therapeutic vaccine for breast cancer developed by Danish biopharmaceutical company Pharmexa.
A spokeswoman for the company told In-Pharmatechnologist.com that this was the company's only customer at present.
Last week, the company reported promising Phase II data from trials of a vaccine designed to treat people who are addicted to cocaine.
