Berkeley Lights, a start-up in Emeryville, Calif., has a vision for the future of cell therapy manufacturing: an all-in-one machine to automate the production, isolation, and culturing of cells for personalized cancer therapies. Berkeley Lights anticipates selling its machines, about the size and shape of two refrigerators, to pharmaceutical companies for centralized manufacturing or to medical centers that want to make the therapies on demand.
If successful, Berkeley Lights’ new model for cell therapy production could accelerate the currently laborious task of making the therapies—a weeks-long process that demands dedicated labs, requires skilled researchers, and commands a hefty price tag. “We think that robotic systems are the way to really scale cell therapy manufacturing,” says CEO Eric Hobbs.
Investors seem to agree. Today, the company raised $95 million from camera and microscope maker Nikon and a large group of venture capital firms to make its cell therapy machine a reality.
University of California, Berkeley, electrical engineer Ming C. Wu cofounded Berkeley Lights in 2011 based on his development of optofluidics technology that uses light to gently push single cells around on nanofluidic chips. “Back then it wasn’t the heyday of cancer cell therapy yet,” Hobbs says.
As such, Wu’s optofluidics technology became the basis of a lab instrument, called Beacon, which Berkeley Lights sells for engineering cells for research purposes. Its customers and partners include Amgen, Catalent, Novartis, Pfizer, Sanofi, Shire, and University of California, San Francisco.
The start-up’s new cell therapy manufacturing system, called Searchlight, is still partly conceptual. A large portion of the $95 million will help the company finish developing Searchlight and get it ready for commercial sale, Hobbs says. “Five years ago, people didn’t even know that cell therapies would work,” he says. “Now people are saying, ‘Oh my gosh, we have to think about manufacturing.’ ”
That’s thanks to the U.S. Food & Drug Administration’s approval of the first two cancer cell therapies just over a year ago: Yescarta from Gilead Sciences and Kymriah from Novartis. Those therapies are both personalized medicines, with each treatment crafted from an individual patient’s own immune cells. That presents a fundamentally new production challenge for drug companies accustomed to making their one-size-fits-all medicines in bulk. The industry is searching for solutions, and Berkeley Lights isn’t alone in its endeavor to provide them.
Some drug companies are spending large sums to build dedicated manufacturing sites for their cell therapies—most of which are still experimental. But other firms, Berkeley Lights included, are hoping to cash in on the cell therapy boom by making manufacturing easier for the drug companies.
For example, the German research supply company Miltenyi Biotec sells a desktop machine called Prodigy that helps automate production of a cell therapy treatment for one person. Octane Biotech, a Canadian medical technology company, and the contract manufacturer Lonza are developing a system called Cocoon, which they envision as a small bioreactor-in-a-box to make a single person’s cell therapy treatment. Berkeley Lights’ Searchlight is bulkier, but Hobbs says a single system could simultaneously manufacture therapies for 25–50 people.
Searchlight’s distinctive feature is its ability to move and manipulate single cells. This allows scientists to screen for engineered cells with the correct modifications, multiply them in an incubator, and reinject them into a patient. That contrasts with current approaches that administer large numbers of cells, which can include unmodified or incorrectly modified cells, with potentially deadly consequences.
“We believe a far smaller number of cells is sufficient. It is all about picking the right cells,” Hobbs says. “And when doses drop, so does the cost.”
Although Berkeley Lights is primarily an engineering company, it made its first foray into therapeutics earlier this year when it launched a joint venture with MD Anderson Cancer Center called Optera Therapeutics. The start-up is still in stealth mode, and few details are available.
“Cell therapy has always been a part of our vision,” Hobbs says. “But the funny thing about the world is that the world isn’t always interested in, or ready to fund, the things you want to do.”