By Laura Fraser, San Francisco based journalist and New York Times bestselling author.
Published 05 November 2020 (this article first appeared on gene.com)
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. Welcome to the experimental playground of Genentech, a member of the Roche Group.
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. 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 Debbie O’Connor, Director, who leads the South San Francisco Cell Culture, Purification and Drug Product Pilot Plants.
But Mike Laird, Vice President of Cell Culture & Bioprocess Operations 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 sandbox, providing a space for innovative and risk taking experiments to see what’s possible,” says Debbie. The energy and excitement of having this freedom to explore is visible and contagious amongst Pilot Plant team members, scientists, and engineers, as all are connected to a common goal of delivering more products to patients faster. “Debbie’s team continuously pushes the boundaries of technical innovation and process optimization, and is also the driving force towards our sustainability commitment,” says Laird.
Even during the COVID-19 pandemic, the Pilot Plants adjusted how they work to provide a safe environment for the staff while continuing our mission to deliver innovative medicines to patients. “It’s an inspiring & fun place to work, with a lot more ideas in a day than there are hours to implement them,” says Laird.