ABOVE IS THE TO BE BUILT MANUFACTURING FACILITY of Continuus on Cabot Road in Woburn, along with an example of a fully integrated manufacturing process that runs 24/7, producing small molecular pharmaceuticals.

MIDDLESEX - A Woburn-based pharmaceutical startup intends to open up the world’s only manufacturing plant capable of mass-producing pharmaceutical products from start to finish.

Continuus Pharmaceuticals, a medical tech firm launched in 2012 as a result of a Massachusetts Institute of Technology (MIT) partnership, earlier this summer announced the start of operations at a 3,000 square foot laboratory at 32 Cabot Road in Woburn, a nondescript side street off of the city’s Commerce Way Corridor nearby Market Basket and the Woburn Village redevelopment at the old Woburn Mall site.

Now, thanks to the success of its tech-driven manufacturing process and an approximate $70 million influx in funding through a government contract with the U.S. Department of Defense, company officials say Continuus Pharmaceuticals can now accomplish what no other company in the world can.

“The Continuus manufacturing model daisy-chains all these unit operations together that are typically [dependent upon outside manufacturers] at multiple sites. You have the efficiency of producing a product in a continuous process from the front to the back,” Ernie Penachio, the company’s vice-president of technical operations, bragged during a Woburn City Council meeting earlier this month.

Penachio appeared before the city officials as the corporation looks to expand production capabilities within a new two-story facility at 32 Cabot Road that was erected in 2018.

The 50,000 square foot building, which contains a combination of office, warehouse, and manufacturing space, sits on a 6.25-acre parcel.

According to Rubin and Rudman attorney Joseph Tarby, who is representing the petitioner, his client is seeking a series of special permits from the council in order to expand the manufacturing floor space from 7,440 square feet to 37,728 square space.

Much of that expansion will happen by converting existing office and storage space into production areas. However, a 7,000 square foot building addition, as well as a three-story “utility” building to store warehouse vehicles and equipment, is also being proposed.

Though Woburn’s Planning Board will determine whether to allow the manufacturing space changes, which are allowed within the underlying industrial zoning district, the City Council is weighing in on the Continuus petition because of its “higher hazard” use of chemical ingredients within an existing flood plain.

Continuus’ existing corporate footprint is already situated exclusively within Woburn, where the firm operates a development and engineering facility along Olympia Avenue and a separate research and development (R&D) headquarters at West Cummings Park off of Washington Street.

The firm’s plans to open-up the world’s only “front-to-back” pharmaceutical production facility comes as the memories of toilet paper shortages and the sight of bare grocery store shelves at the outset of the COVID-19 crisis are still fresh in minds of many.

Continuus’ pitch also comes as those initial supply-chain shortages have continued until this day. With the breakdowns impacting everything from the price of lumber and pool chlorine tablets this summer to the availability of the semi-conductors and computer chips that power automobiles and small electronics, some of the more frightening shortages over the past 18-months left emergency room doctors and personnel scrambling to find medical grade masks, ventilators, and life-saving medications.

Countless politicians and media pundits have since proclaimed that in the interest of national security, the country needs to restore swaths of the United States’ lost manufacturing sector, especially when life-saving medical equipment and medicines are almost entirely dependent upon foreign production lines.

Given that background, the magnitude of Continuus Pharmaceuticals’ plans was far from lost on Woburn’s City Council.

“I think this is amazing, and I’m so happy you’ve decided to do it here in Woburn,” responded Ward 5 Alderman Darlene Mercer-Bruen, whose district includes the Cabot Road site and the firm’s other R&D facilities.

“I’m hoping other people are paying attention to what your doing, because the supply-chain issues are not limited to pharmaceuticals. I applaud you,” continued Mercer-Bruen, a Winchester Hospital staffer who recalled various instances where the supply-chain shortages threatened to impact operations at area medical facilities.

According to Penachio and other Continuus representatives, the current production of everything from over the counter cold and cough medicines to antibiotics and vaccines is almost entirely dependent upon a compartmentalized manufacturing process that takes place in distant locales across the globe.

Under that system, most raw ingredients needed to make pharmaceuticals are shipped to plants in China and India, where lower-paid factory workers manufacture so-called active pharmaceutical ingredients or APIs.

For American pharmaceuticals, many of those APIs are then shipped back across the Pacific Ocean and into West Cost ports, before they are trucked to plants across the country and combined to create final products.

“This is a fairly traditional supply-chain and 70 to 80 percent of the drugs we have here in the United States follow this process,” the vice president explained during this month’s council meeting.

According to Continuus officials, with foreign competitors able to produce API’s much cheaper due to lower wage standards and much looser environmental regulations, overcoming that financial deterrent stands as the biggest obstacle to bringing the entire manufacturing process back to the United States.

To overcome that challenge, firm founders Salvatore Mascia and Bayan Takizawa turned to technology and created a new “integrated continuous manufacturing (ICM)” model that streamlines the entire process.

Under ICM, smaller factory footprints, such as mobile laboratories being marketed by Continuus, illustrate how the entire production process can be streamlined from the introduction of raw materials to the output of a final product.

“To change this outdated paradigm, Continuus Pharmaceuticals is leveraging a novel continuous manufacturing platform called ICM… initially developed at the Novartis-MIT Center for Continuous Manufacturing, a $85 million joint research endeavor,” reads company materials posted to its website.

Company officials contend that besides shrinking down equipment, improving yields, and decreasing the amount of manpower needed to produce final pharmaceutical products, its state-of-the-art ICM process has been shown to reduce overall development costs by a range of 30 to 50 percent.

“The only way to compete is to use technology to drive-down costs…There’s not another facility in the world that does this. It’s a very innovative first-of-its kind development,” said Penachio of the company’s Cabot Road production plant.

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