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Saturday

 

The high-stakes art of turning cells into drugs

























Sophia Koutoulas, the director of manufacturing at Biogen in Cambridge, started out as an intern; today, she supervises about 160 employees.

Sophia Koutoulas climbed the ladder at her shop. She started as a temporary intern on the shop floor, worked her way up to become a full-time production worker, earned a promotion to supervisor, and eventually was named director of manufacturing.

But in her case, the “shop” is a 66,000-square-foot manufacturing plant at Biogen Inc.’s headquarters and research campus in Kendall Square.

There, she supervises about 160 workers operating five bioreactor stations, called “trains,” each consisting of three stainless steel tanks in which the company makes multiple sclerosis and hemophilia drugs from living cells.

“Our work ethic is pretty intense,” said Koutoulas, a 41-year-old Peabody native. “We run 24/7 — rain, shine, holidays, it doesn’t matter. Our cells have to grow, and they have to be harvested. We work long hours, long days, and we have a dedicated overnight shift.”

During her 18-year career, Koutoulas has done just about every job in Biogen’s bioprocessing operation: cleaning and assembling equipment, preparing and running bioreactors, and growing cells in the “hood” —a glass-shielded safety cabinet — before they’re transferred to the tanks.

Biogen also has manufacturing sites in North Carolina and Denmark and is building a larger production plant in Switzerland to accommodate its growing pipeline of medicines.

At the Cambridge plant, the company’s oldest and smallest, it makes two multiple sclerosis drugs, Avonex and Plegridy, as well as Eloctate, for the treatment of hemophilia A.

In her current management post, Koutoulas said, “my job is to oversee the organization and make sure we know what the production rate is going to be. We’re committed to making a product of quality. But we also want to keep our employees engaged, to provide opportunities.”

Koutoulas presents a calm exterior, but she is well aware of the high stakes of biotechnology manufacturing. If a batch of cell culture is contaminated — as happened at the Genzyme bioprocessing plant in Allston about five years ago — patients could be hurt.

“I feel pretty confident with the systems we put in place,” she said. “We’ve learned from our mistakes and from others’ mistakes on how to have the proper risk-mitigation strategy.

“We also have sister facilities we could leverage if something went wrong. It’s incredibly important that we always have product of quality available to our patients.”

Robert Weisman can be reached
at robert.weisman@globe.com.
Follow him on Twitter @GlobeRobW.

Story Source: The above story is based on materials provided by THEBOSTONGLOBE
Note: Materials may be edited for content and length


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