Center for Cellular Engineering Unveils New Manufacturing Facility

The Modular Terrace Facility will be used to produce cutting-edge cell and gene therapies for clinical research trial patients

The Center for Cellular Engineering (CCE) recently unveiled its new, roughly $20 million Modular Terrace Facility.

First conceived in 2017, the custom-designed, 8,000-square-foot structure features four manufacturing clean rooms spanning 3,000 square feet and another 1,000 square feet of support space.

"There's no research space in this building. It's all dedicated to manufacturing," CCE Deputy Director Dr. Rob Somerville says. Unlike most commercial facilities, which focus production on one or two cell or gene therapy products, the CCE oversees a broad portfolio.

Somerville says the new Modular Terrace Facility will directly support the CCE's mission to produce therapies for patients enrolled in trials.

These range from stem cells for bone marrow transplants and CAR T-cell immunotherapies for cancer patients to the CCE's most advanced product, a graft of retinal pigment epithelial cells for patients with macular degeneration.

To produce epithelial cells, CCE staff reprogram blood cells drawn from a patient sample to create iPSC, or induced pluripotent stem cells, a form of lab-generated embryonic stem cell.

"We then select basic cultures of these cells, pick the best one, and then … go through a differentiation process to turn them into retinal pigment epithelial cells," Somerville says.

The cells are later transferred to a scaffold used by an ocular surgeon to implant into a patient who has suffered vision loss caused by macular degeneration.

"This is first in human. So far only a single patient has been treated with this therapy," Somerville says, noting that the manufacturing process is protracted. "It takes multiple months, and we're still just a proof of concept stage."

Noting that requested cell and gene therapies for Clinical Center patients are constantly in flux, the scientist says the CCE's new Modular Terrace Facility will increase production capacity.

"We can manufacture different products in different rooms, and they won't impinge on whatever is going on in adjacent rooms, which gives us a lot of flexibility," he says.

A key feature of the state-of-the-art facility is that it can be easily cleaned—a crucial requirement to ensure a sterile manufacturing environment to produce patient products free of hospital-acquired infections.

"This facility is a new tool that NIH can use for [many] years looking forward," Somerville says. "Rather than designing a facility for where we are now, we've created flexibility … It is forward thinking."

- Sean Markey