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Leveraging on its recent investments Senrise-IV and Senefill, Novasep launches a unique
2-year turnkey plant offer to accelerate commercial production of viral vectors.
Novasep, a leading supplier of services and technologies for the life sciences industry, presents oXYgeneTM, a new offer for construction and operation of customer dedicated facilities for viral vectors production.
Novasep recently announced the successful start-up of Senrise-IV, its flagship for bioproduction of viral vectors at large scale. Novasep now offers to capitalize on its unique engineering and CDMO expertises to shorten the time-to-market of its customers late-stage viral vector drug candidates. Novasep’s modular bioproduction unit is composed of two cGMP production lines, dedicated to either adherence cell culture for low volume production or suspension cell culture with bioreactors of 50 to 2000 liters for larger volume production.
The oXYgeneTM solution goes much further beyond the supply of a turn-key production suite. For oXYgeneTM leverages Novasep’s platform facility design solution to accelerate all project phases: procurement, commissioning & qualification, validation and training. Indeed, oXYgeneTM consists of building and staffing the plant and performing cGMP viral vectors production for Novasep customers. In the meantime, Novasep has built expansive Fill & Finish capabilities with its new unit Senefill, which will be fully operational by end 2019, to supply oXYgeneTM customers from production to release of their viral vector drug products at commercial scale, on the same site.
The global gene therapy market size was valued at USD 536.43 million in 2018 and is expected to register a CAGR of 33.9%. oXYgeneTM is a response to the strong market demand driven by both a growing interest in this therapeutic approach and a maturing clinical pipeline. For example, viral vectors are used in gene therapies or immunotherapies such as new cancer treatment strategies and in "new generation" therapeutic vaccines.
“I am proud to see that Novasep has pioneered the future of innovative therapies manufacturing and that we are now able to offer excellent, faster, tailor-made and on large scale services for the ever-growing viral vectors needs.” commented Michel Spagnol, Chairman & CEO of Novasep Group.
“oXYgeneTM is the natural extension of our Senrise-IV facility and is commercially available now. We capitalize on our unique know-how and experience to accelerate the production and delivery of viral vector products. In the biopharmaceutical area, time-to-market, security of supply and manufacturing costs are key. With oXYgeneTM, we can meet these challenges and deliver a validated, fully staffed production plant in 2 years!” said Jérôme Bédier, Vice President, Biopharma Operations, for the Manufacturing Solutions Business Unit.
Source: www.grandviewresearch.com- Gene Therapy Market Size, Share & Trends Analysis Report By Vector (Lentivirus, RetroVirus & Gamma RetroVirus), By Indication (Beta-Thalassemia Major/SCD, ALL, Large B-cell Lymphoma), And Segment Forecasts, 2019 – 2026