Every innovation hinges on a risky proposition: convincing an industry that a new approach might be better. For Salvatore Mascia, it’s pharmaceutical manufacturing that’s in need of a redesign. The current process is too long and inefficient, and there’s been little incentive to make any wholesale change. Mascia hopes to do that with CONTINUUS Pharmaceuticals, the company that he founded in 2012. As the name implies, and with the help of MIT technology, it’s a single process approach in which all the steps are integrated and handled in one room, saving both small and large companies time and money and providing speed and flexibility in getting their products to market with higher quality. “The future of this is exciting. The FDA has positioned this technology among the top of their strategic priorities, and they’ve been extremely supportive of it,” Mascia says.
Think of a pipe The company came out of the Novartis-MIT Center for Continuous Manufacturing. Mascia had been its strategic project manager from 2009-2012 and saw the potential and need for a new technology. The long-time standard pharmaceutical approach has been batch manufacturing, a series segmented steps. The process is long and expensive, but it has remained, because with big companies putting out blockbuster drugs, there had been generous margins and little financial need to change, Mascia says.
But the economy and industry shifted over the last decade. Specialized drugs and generics continued to grow; efficiency and cost-effectiveness became critical, Mascia says. CONTINUUS Pharmaceuticals licensed the technology from MIT, and with $200,000 and a partnership with I.M.A. (Industria Macchine Automatiche), started the company in 2012, first next door to campus at the Cambridge Innovation Center before moving in 2014 into its own almost 4,000 square-foot facility about 10 miles away in Woburn, Massachusetts.
Because of the continuous flow, there is minimal amount of in-process volume per unit time, which allows for better control, better performance and higher quality outputs.
With its continuous manufacturing system, all the steps – reaction, separation, crystallization, filtration and drying and formulation – would now be integrated into one single system, avoiding unnecessary stops-and-starts and isolations of intermediate products. Because of the continuous flow, there is minimal amount of in-process volume per unit time, which allows for better control, better performance and higher quality outputs. “This method requires the use of new techniques, and our approach has been to develop the next generation of pharmaceutical manufacturing technologies to run the process continuously from front to back,” he says.
Mascia says to think about it like a pipe. Raw materials are put into one end and the finished product comes out the other. The process provides a consistency by being fully automated, 365 days a year, 24 hours a day. But it also allows for quicker output. As just one example, Mascia says that where something like a blood pressure drug would require 200 days to produce in the current system, his method can do it in two. “This is a real transformation for the industry. It will not only enable to produce pharmaceuticals faster than before but it will allow them to be produced on demand,” he says.
The big and bigger pictures While both large and small pharmaceutical companies have different scales budgets, both are targets of CONTINUUS’ technology. When it to comes to producing generics, almost half of the costs are tied up in manufacturing, making any kind of savings a necessary element in staying competitive, Mascia says. Big drug companies might not necessarily have the same pressing concern, but they do want speed to market and to have maximum flexibility in ramping production up or down. “Having the technology that addresses both will be a tremendous advantageous for any company,” he says.
It’s those combined qualities – lower cost and responsiveness – which Mascia says will also help with issues like epidemics and critical drug shortages. His company has the ability to produce quickly, and in the Third World, something like HIV medication now becomes a more affordable venture.
Mascia says that CONTINUUS has raised more that $3 million and earned close to $1 million in revenue in 2015. With continued growth, he ultimately wants to be able to house the entire process. By being able to make and sell directly, the supply chain would be shortened and patients would see less expensive drugs. The technology would fulfill another goal of shifting more manufacturing back to the United States.
As it stands, about 85 percent of active ingredients come from abroad, he says. Because of the costs and the segmented nature of batch production, much of the work is outsourced to places where labor is less expensive, regulation is less strict and quality then suffers. By being able to keep assets in the country, the variability of incoming raw materials will decrease, improving product quality, and medicine would become more personalized. “We can change this,” he says.
Having the MIT connection is a significant advantage in the effort, Mascia says. Along with the initial technology, the Institute helped and continues to help the company’s development through its mentoring services and operational labs. That kind of support has kept startups close to campus, creating a competitive mindset and making the area into an innovation hub. Mascia says Boston and Cambridge are already the center for developing new drugs, and he wants to make it the same for manufacturing, adding, “I think really we’re in the best place in the world to make this business successful.”