Biosafety Inspections in Bedford Reveal Only Minor Issues

July 21, 2023
Ultragenyx is just one of the 13 Bedford bioengineering facilities getting a positive report after an annual biosafety inspection. Courtesy Image Ultragenyx

The scientist who handles annual biosafety inspections at local firms in Bedford told the Board of Health this week that there are no serious issues.

Rebecca Caruso reported that this year she returned to in-person inspections, after three years of pandemic-driven virtual checks.

The local health regulations call for the inspector to review permits and check laboratories. She visited 13 companies (a 14th, Prolacta, recently opened and the inspection was virtual). “Every year I see a lot of best practices,” Caruso said.

“Overall, I would say housekeeping was very good,” Caruso reported, noting that the firms all had strong reserves of personal protective equipment, as well as emergency gear like first-aid kits. Companies also had good records of emergency training, she reported. 

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Caruso said she tells managers what they are doing well and what needs to be improved. “I make sure they’re using safe equipment in a proper manner,” she said, and that there are safety rules when using higher-risk materials.

She said a few labs needed reminders about safe handling of materials. Other occasional points were scheduling required meetings of institutional biosafety committees; cleaning issues involving some lab equipment; missing biohazard signage, late certification of equipment. 

“We talked about the idea of emergency pendants, especially for anyone working alone,” she said.

Caruso, director of Harvard Medical School’s Committee on Microbiological Safety, has been conducting inspections of bioengineering facilities in multiple towns for 15 years. 

“I’m happy to keep doing this,” she told the board.

She said she is considering assembling a pamphlet to inform labs in advance about the inspector’s priorities. 

“Occasionally they find something in the regulations that they didn’t know about,” she said.

The 13 firms inspected were Beryllium Discovery, Conagen, Frontera Therapeutics, Homology Medicines, Millipore Sigma, Obsidian Therapeutics, Ocular Therapeutix, Oxford Biomedica, Sophion Bioscience, Stoke Therapeutics, Thermo Fisher Scientific, UCB Boston, and Ultragenyx.

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