Trending Now: cGMP Facilities
February 12, 2021
By: Stephen Hassel + Kristen O’Gorman
As the Life Sciences sector continues to boom, demand for cGMP facilities grows, particularly in regions that are already home to a significant number of biomedical and pharmaceutical corporations. That’s why the experts at the Boston- and New York City-based architecture, interior design, and planning firm SGA recommend that owners and developers in these areas tap into this lucrative market, with build-to-suit or speculative projects.
“CGMP stands for current Good Manufacturing Practices,” explains Stephen Hassell, SGA’s Vice President of Business Development. “New facilities must meet FDA standards for cGMP in order to safely and successfully product medications and associated products.”
Kristen O’Gorman, LEED® GA, NCARB, and SGA Associate, Senior Designer, and Architect, notes that the architectural, structural, and MEP (mechanical, electrical, and plumbing) layouts of a cGMP facility differ from those of a Class-A Life Sciences building, due to the need to maintain a secure, controlled, and aseptic environment. “For example, the provided shell volume is typically around 32 feet high, because we need to accommodate a clean room, a walkable ceiling, and mechanical mezzanine, so that necessary maintenance can be performed without compromising the clean environment. Warehousing may take around 20% of the overall square-footage, and is ideally within a high bay environment.”
Proper circulation is also very important, O’Gorman says. “There needs to be a one-way circuit through the space, from the loading docks that receive supplies, to entry corridors, to clean rooms, to production, to packaging, to high-bay warehousing, and back out to another set of docks to load trucks with the finished product.” (A third loading dock is usually required for waste removal, she adds.)
Throughout, Hassell says, there are numerous FDA-required validation processes, which assure adherence to all production procedures and standards. “A tremendous amount of data must be collected at all times, at each step in the manufacturing process. Every room has a temperature and humidity monitor, for example, to ensure an optimal production environment. Some systems, like power and IT, need to be redundant, so that ongoing experiments and production won’t be compromised by potential interruptions. There is also the need for a constant supply of process gases.”
These cGMP facilities are increasingly needed in mature Life Science markets because of a growing desire to keep the drug manufacturing, packaging, and distribution processes in close physical proximity to the labs in which said drugs were originally developed. “Central Square, in Cambridge, is ground zero for biotech and pharma,” says Hassell. “There are 160 companies per square mile. Everybody wants to be there. The big pharma companies invest in smaller biotech firms, and when they come up with something promising, they want to keep the entire process nearby. Owners and developers in these markets do well to support each step of the drug discovery pipeline.”
“Particularly if you have an underperforming office building in a sub-optimal location, or are planning a massive new campus for Life Sciences, cGMP facilities are something you should think about,” Hassell says. With a high-demand facility type in a high-demand industry, the potential upside is considerable.