French drugmaker Sanofi Genzyme has completed process qualification runs at a plant in Framingham based on digital and continuous biologics production technologies.
Sanofi announced today that following successful process qualification runs in the last quarter, it has inaugurated a digitally-enabled, continuous manufacturing facility at its site in Framingham, Massachusetts.
Nicolas Kressmann, a spokesperson from Sanofi, told Bioprocess Insider that the plant represented an investment of €290 million ($320 million) between 2014 and 2018. The French Big Biopharma firm spends around €1 billion each year on transforming and modernizing its production facilities.
While capacity and equipment details were not disclosed, Kressmann said the plant features “Digital Twins” as part of its next-generation platform.
This involves a “digital copy of operating and software environments, which allows site managers to make adjustments on the go and simulate manufacturing process changes,” he explained.
“It is also used as a training tool where operators, managers, and supervisors can interact with the process, the equipment, and the software in this virtual environment before they do so in the live environment.”
Framingham is one of the first plant in Sanofi’s network to be described as ‘fully digital’ but the firm intends to carry out a “digital transformation” across its network in efforts to “leverage better use of data to optimize the company’s manufacturing processes, increasing efficiencies, improving the agility needed to respond to fast changing patient needs, and speeding up the commercialization of new medicines emerging from the R&D pipeline.”
No new jobs are to be created on the back of this plant, but Sanofi employees will receive training on the intensified, continuous biologics platforms.
Framingham makes numerous products for Sanofi Genzyme, including Fabry Disease enzyme replacement therapy Fabrazyme (agalsidase beta) – production of which was moved to the site in 2012 after contamination issues at Sanofi’s Allston Landing, Massachusetts plant.
Details of which biological products will be made at the latest facility on site remain undisclosed, other than being described as products in Sanofi Genzyme’s Specialty Care portfolio. The firm’s portfolio can be found here.