With this new Viral Vector bioproduction facility, Novasep confirms its leadership position and effectively addresses the growing gene therapy market demand
Lyon, France, October 2nd, 2018 – Novasep, a leading supplier of services and technologies for the life sciences industry, has opened a new 27 M€ viral vector production facility in Seneffe, Belgium. The production of thefirst cGMP batches will start in H1 2019.
This project, known as Senrise-IV, represents an operational and strategic step forward for Novasep. This facility features the bioproduction of viral vectors at commercial industrial scale in an integrated manner and with full control of the value creation chain. To this end, Novasep has doubled its on-site workforce with the creation of 75 positions.
The facility will feature two cGMP production lines: one dedicated to adherence cell culture for viral vectors in moderate quantities – to treat certain rare diseases or for lower dose indications – and one for suspension cell culture with bioreactors of 50 to 2000 liters to produce larger quantities. This equipment is designed to meet the growing demand of biopharmaceutical companies worldwide.
The 2,000m² Senrise-IV facility meets the highest cGMP standards governing commercial production for biopharmaceutical use. A zero-risk approach thus remains a core priority with the separation of different production zones and effluent and material onsite decontamination.
“We are delighted to inaugurate this facility today. It was built in record time thanks to the unwavering support of our experts’ team. We are now able to offer the market commercial production in addition to clinical production,” said Pierre Lunel, Director of the Belgian site.
“In addition, the construction of ‘Senefill’, our fill & finish commercial facility is ongoing on the same site, and will be operational before the end of 2019. This investment will allow Novasep to provide standalone fill & finish services or integrated drug substance and drug product manufacturing for viral vectors, mAbs and other low volume biologics. We remain committed to efficiently respond to the strong market demand for orphan and targeted biopharmaceutical drugs as clinical pipelines mature,” commented Michel Spagnol, Chairman and CEO of Novasep.
Novasep is a global provider of cost-effective and sustainable manufacturing solutions for life sciences molecules and fine chemicals. Novasep's unique offering includes process development services, purification equipment and turnkey processes, contract manufacturing services and complex active molecules to serve pharmaceutical, biopharmaceutical, fine chemical, food and functional ingredients as well as fermentation and chemical commodities industries.
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