Production of first batches at new EUR27m, cGMP manufacturing facility is due in early 2019
Novasep, the molecule production and purification specialist, has announced the opening of its new viral vector production facility. Located in Seneffe (Belgium), the EUR27m manufacturing site is scheduled to produce the first cGMP bathes in the first half of 2019. Headquartered in Lyon, France, Novasep caters to life science and chemical industries.
“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.
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 a line for suspension cell culture with bioreactors of 50 to 2,000 litres to produce larger quantities. This equipment is designed to meet the growing demand of biopharmaceutical companies worldwide.
Novasep said the 2,000sqm 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.
Lunel said construction work on the Senefill, Novasep's 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," Michel Spagnol, Chairman and CEO of Novasep, commented.
"We remain committed to efficiently respond to the strong market demand for orphan and targeted biopharmaceutical drugs as clinical pipelines mature,” he concluded.