- Sanofi's new manufacturing plant in Framingham, Massachusetts, will produce 80% less carbon dioxide emissions compared to the company's first-generation facility and will reduce water and chemical usage each by more than 90%, according to details released by the company.
- The company's new facility opened last month and uses continuous manufacturing, a production method commonly used in other sectors but only slowly adopted in the pharmaceutical industry.
- Sanofi says the facility will connect research and development processes with production, which it hopes will speed up the time to market for new medications.
Efficiency and substantially faster speed are often cited as the main benefits of continuous manufacturing.
"The gains in environmental impact are based on a number of factors," a Sanofi spokesperson explained in an email to Supply Chain Dive. "The application of continuous processing further enables reductions in [equipment] size and scale as the process can run 24 hours a day and 7 days a week to maximize the production capabilities of smaller unit operations."
The change in method allows Sanofi to use small equipment that results in "significant reduction" in the energy, chemical and water used in the cleaning process, the spokesperson said.
Continuous manufacturing is an alternative to the batch manufacturing that's been the standard operating procedure for drugmakers for decades. Rather than run a multi-step process with interspersed production stops, continuous manufacturing features an end-to-end assembly line that churns out product at the same time as inputs are added in.
"Most processes that process a large volume of material typically tend to operate in a continuous manner because it's much more efficient," Piero Armenante, a professor of chemical and materials engineering at the New Jersey Institute of Technology, told Supply Chain Dive in an interview.
Cleaning is one of the important steps of batch processing in pharmaceutical manufacturing, Armenante said. "During that time the reactor is just sitting there, you're doing something to clean it up or to prepare, but you're not using it, which is not true if you have, say, a continuous process," he said.
These are benefits Janet Woodcock, the director of the Center for Drug Evaluation and Research at the Food and Drug Administration, was already citing as far back as 2011.
While the pharma industry hasn't followed Woodcock's words as quickly as she perhaps hoped, more and more drugmakers are experimenting with and introducing the production method.
Vertex, Johnson & Johnson and Eli Lilly have all won FDA approval to use continuous manufacturing to produce some of their marketed drugs, such as Lilly's breast cancer medicine Verzenio (abemaciclib).
Art Hewig, the executive director of pivotal drug substance process development at Amgen, said the biotech began overhauling its manufacturing process in 2010, according to notes from a continuous manufacturing workshop published by The National Academies of Sciences, Engineering and Medicine.
The business case for continuous manufacturing will differ for each business. But it can result in it "shrinking the manufacturing footprint [resulting] in a significant reduction in capital investment and the time needed to deploy a new process. It also enables miniaturization and intensification of process workflows," Hewig said, according to the Academies' notes.
For now, though, the use of continuous manufacturing in the pharmaceutical space is not common, Armenante said. The processes of overhauling the supply chain for a highly regulated industry like pharmaceuticals is no easy task.
"You will see more and more of these processes becoming become more continuous," Armenante said. "There's definitely movement in that direction in trying to essentially have the whole train of operations strung together so it can generate a continuous process."
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