Posted on Oct 17, 2019 at 4:21 PMUpdated Oct 17, 2019, 4:35 PM
Steel fermentation tanks, a tangle of pipes, chromatographs behind large bay windows… At first glance, the bio production unit inaugurated by Sanofi this week in Framingham, near Boston, does not seem so different from this one. conventionally found in this type of installation. However, there are real differences, which place this Sanofi site at the forefront of innovation in organic production. The French laboratory has invested 290 million euros on this former Genzyme site,
To give an idea of the productivity gains, it is necessary to specify the size of the bioreactors: only around one hundred liters, whereas they are for example 80 times larger in the current process used to manufacture Fabrazyme or Cerezyme, two drugs against rare diseases. Clearly, Sanofi has developed a process that allows it to produce 80 times more productively, thus allowing a big saving in cost and space.
Another difference is that this is a permanent production. The cells housed in the bioreactors, which make the therapeutic proteins, receive the nutrients by continuous infusion. The proteins are collected as soon as their concentration reaches a certain level, without having to stop the process as is the case in the usual batch production.
The inside of the bioreactors is also lined with a single-use plastic bag, which avoids the long cleaning operations essential before launching the manufacture of a different product. This trick can reduce water and chemical consumption by around 90%, and energy consumption by 80%.
Finally, this factory, the first “digital native” of the group’s production network, was designed for digital management. Tablets and wall screens display real-time readings of production parameters to anticipate any possible process drift, monitor quality control or safety indicators at work, or even all the instructions associated with a workstation , etc.
Agility and flexibility
The interest in developing such a tool is for Sanofi to improve the productivity, agility and flexibility of its production in order to switch more easily from one product to another, and therefore to better adapt to fluctuations in demand and avoid possible shortages of life-saving drugs.
Intended to manufacture the biological drugs of the group’s specialty medicine portfolio, the site successfully carried out the qualification tests of its processes in the third quarter of 2019, and hopes to have the green light from the American authorities for its commercial start before the end of the year.
“This factory gives a boost to the transformation initiated at the level of the organization of production. It is now more oriented towards the manufacture of biological drugs, in line with the transformation of the R&D pipeline ”, explains Philippe Luscan, the man who heads industrial affairs at Sanofi.
Five other sites
This factory also plays a pilot role. The digital innovations implemented there will be deployed first on the group’s five other pilot sites, namely the vaccine plant in Toronto (Canada), the traditional pharmacy site in Suzano (Brazil), the site of chemical synthesis of Sisteron (France) and the bio production units of Geel (Belgium) and Waterford (Ireland).
They will then be standardized and deployed on all of the company’s industrial sites by 2021. The group, which has already invested nearly 5 billion euros over the past five years in the modernization of its industrial facilities , plans to devote an additional 20 million to its digital transformation.