STC opens GMP biologics plant, eyes commercial and gene therapies

Self-proclaimed ‘boutique CDMO’ STC Biologics has begun initial runs from its newly constructed single-use mammalian plant in Newton, Massachusetts.

Contract development and manufacturing organization (CDMO) STC Biologics has undertaken its initial master cell bank (MCB) and three drug substance production runs at its new 3,500 square-foot facility, close to Cambridge, Massachusetts.

The plant, which could create up to 30 jobs, brings Good Manufacturing Practice (GMP) manufacturing capabilities to the firm at a 500 L bioreactor scale, expandable to 1,000 L.

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“We have been working on building the facility for one-and-a-half years and it has been a multi-million dollar investment,” Magdalena Leszczyniecka, CEO of STC, told Bioprocess Insider.

“We will have capacity for up to 10 full programs, from cell line development to Phase I/II drug substance manufacturing, per year.”

The facility is equipped with single-use equipment, including a Thermo Fisher supplied HyPerforma 500 L single-use bioreactor, Finesse controller system, and ÄKTA Ready purification skids from GE Healthcare.

Boutique biologics and an eye for expansion

STC describes itself as a ‘boutique CDMO’ due to its relative size.

“Our size allows to be nimble and fast and provide customized services for the innovative products that are being developed, particularly in Cambridge-based start-ups,” Leszczyniecka said.

She added the CDMO will continue to grow to fulfil its customers’ needs.

“There are two areas in which we are considering to increase our position [in the CDMO space]. The first is gene therapy. The second is to build another biologics production facility that can handle production up to and including commercial product, to allow for development continuity for our clients.”

Local advantage

The firm also claims the expanded offerings makes it the largest biologics CDMO within five miles of Cambridge, Massachusetts. The location is often cited as the world’s largest hub of biologics R&D (though some on the West Coast might disagree).

In a BPI TV interview taken in Boston last September, Leszczyniecka said being near its clients is advantageous for STC.

“We’re in the hub of biotechnology here [in Cambridge] and there’s really no CDMOs with any GMP capabilities that are local,” she said at the time.

“I think people are starting to grow really tired with communicating with companies across the ocean and waking up at 6am or 10pm at night to have a teleconference and not understanding some of the data they are getting, because obviously there are some cultural differences or even just the way people approach things in other countries. So being close to the client and having that proximity makes it easier for [our clients].”