A medical school in the U.S. has built a large-scale manufacturing facility to overcome bottlenecks in adeno-associated virus (AAV) production.
The AAV large-scale manufacturing facility, which opened in June at the University of Massachusetts (UMass) Medical School in Worcester, aims to help address a shortage of viral vectors for preclinical research.
“There’s a bottleneck in availability of these products,” says Sylvain Cecchini, PhD, an associate professor of microbiology and physiological systems at UMass Medical School and the facility’s director. “If you’re doing research in a lab, you’re fine, but the purpose of biotechs is to bring research to commercialization.”
Researchers conducting large animal studies before moving into Phase I trials need large amounts of AVV vectors, he argues, but few companies are currently producing vectors at a sufficiently large scale.
“People initially didn’t realize vectors for research could be a bottleneck,” he explains. “The situation is getting better, but the prime CMOs [contract manufacturing organizations] are saturated [with customers].” As a result, researchers often wait 12 to 24 months to obtain enough AAV for their studies, he says.
The new UMass Medical School facility, which is part of the medical school’s Horae Gene Therapy Center, uses a Sf9 baculovirus expression system for high-quality, research-grade AAV production. According to Cecchini, this system produces higher product volumes than more traditional mammalian systems for AAV production and the process is portable to CMO and GMP facility.
In addition, the Sf9 insect cells can be grown in suspension, which he argues, makes the production volumes easier to scale up. The facility currently has a 200 L production capacity with an aim to increase to 500 L.
The facility also plans to offer a wider variety of capsids to potential clients. “At the moment, we’ve just opened our facility, so we’re still making plans for this year and starting to talk to clients,” he says.
The facility is open to academic and industry clients. Cecchini recommends that potential customers visit the facility’s website and use the contact form to get in touch.