In October 1996, Genentech opened the doors to its Pilot Plant, a manufacturing test facility where scientists and engineers determine the best way to make medicines at larger scales. They tinker with the processes and equipment, sometimes hundreds of times, before new techniques are used to make the medicines for patients in the “real” manufacturing facility. The Plant hums 24/7 with these MacGyver-like scientists and engineers who are conducting thousands of scientific experiments to find the fastest and most reliable way to make medicines.
In the Pilot Plant, teams test large-scale cultures of cells that produce molecules that make up medicines. Starting with just a few cells in a tiny test tube, the cells rapidly grow and multiply to trillions of cells as they are transferred into larger tanks of up to 1,000 liters, about the size of a small car. The molecules produced by the cells are then carefully tested to be sure they are safe and effective. “There are a lot of challenges going from small-scale to large-scale production, and cell cultures in particular have many variables that can go wrong,” says Jeff Davis, who leads the operations and engineering group that includes the South San Francisco Pilot Plant.
But Mike Laird, director of early stage cell culture in process development, says the scientists live to tackle those kinds of challenges. “Sometimes the cells just don’t grow, the cultures get contaminated, or we have to figure out the best ways to feed the cells to keep them happy,” he says. “The equipment can also clog or fail, or—as happens periodically—the cells can foam over the top of the tank like a washing machine with way too much soap.”
But more than being a facility to test processes, the Pilot Plant is also a kind of playground for scientists and engineers to experiment in a safe environment. “We’ve done some really crazy things over the years that we never could’ve done without a practice plant,” says Laird. Once, when scientists puzzled over how air was getting inside a chromatography column—a system that separates the medicine molecules from surrounding gunk, and cannot work with air inside—they joked that they wanted to send a scuba diver in. That sparked a solution: Send a GoPro camera inside the column while it was running. They got the data they needed.
“The Pilot Plant is an entrepreneurial environment,” says Lynne Krummen, head of pharma technical development biologics in the U.S. “It gives people the space and the ability to run experiments and to think innovatively.” That’s why people like Laird like to come in at night and on holidays to fiddle around and perfect the processes. “They’re enthusiastic,” Krummen says, “because they know they have an important role in getting the next new medicines to patients.”
Experience 24 hours of life at the Pilot Plant—in under a minute. Video by kontentfilms: