- Sanofi unveiled Tuesday a roughly 100,000-square-foot biologics manufacturing plant in Framingham, Massachusetts, touting the facility as a key cog in a broader plan to retool its production base.
- The new site will use continuous manufacturing rather than traditional batch processing, a change the industry has generally been reluctant to make. Relying on single-use equipment, the plant will use less energy and chemicals, executives said, while boosting productivity versus a typical set-up.
- Sanofi has spent about $320 million over the past five years on the Framingham facility as part of a company-wide, multi-billion dollar restructuring. The plant has produced its first commercial qualification lots for regulatory review, and executives said they expect the site to be approved by the FDA late next year.
Sanofi's new CEO Paul Hudson, a month into his tenure succeeding Olivier Brandicourt, attended Tuesday's plant opening, one stop in a tour of the company's expansive holdings.
Those trips will culminate in a Dec. 10 event, event where he'll present his future strategy for the company at Sanofi's Cambridge, Massachusetts office.
That strategy is likely to include many of the attributes highlighted in the Framingham facility: a focus on biologics, digital technologies and productivity.
The Framingham plant is sited to take advantage of its nearby location to Sanofi's R&D operations in Cambridge. Co-locating R&D and manufacturing in key geographical hubs — Boston, Paris and Frankfurt in Sanofi's case — are aimed at helping the drugmaker speed development times.
Dean Morris, the program director for Sanofi's Framingham campus, said the new plant can quickly adapt to changing demands of what needs to be produced. Transitioning between producing different medicines, which typically takes months or weeks, could be shortened to days or hours.
On a Tuesday walkthrough of the lab, Sanofi employees also highlighted the digitalization effort, which includes several large touchscreen boards to monitor real-time statistics on safety, quality and cost, as well as computer systems placed throughout the production area to access maintenance files digitally.
"We will not see any paper, I hope, in the plant," said Philippe Luscan, Sanofi’s executive vice president of industrial affairs. "Which is a big evolution."
While manufacturers in many industries have rapidly modernized, drugmakers are frequently wedded to decades-old processes as changes often require regulatory sign-off.
The new plant avoids some traditional, cumbersome manufacturing processes by digitizing and streamlining approval of a production batch, a process which can require 10,000 pages with multiple signatures on each page.
Hudson said Sanofi's manufacturing capabilities and personnel are an asset, particularly as therapeutics have become more personalized and complex in recent years. The company gained its Massachusetts presence when it paid more than $20 billion to acquire Genzyme in 2011.
"This very specific know-how must be protected, because your manufacturing capability can and should become a competitive advantage over the long term," Hudson said. "For many years, it was a little bit taken for granted."
The French pharma giant has spent about 5 billion euros, or approximately $5.5 billion, over the past five years on its manufacturing capabilites.
While company executives declined to say which biologics would be manufactured at the Framingham plant, they did say it would focus on Sanofi Genzyme's specialty care segment, which includes medicines for multiple sclerosis, cancer and blood diseases.