Though largely operating in the background until recently, Prolific Machines’ optogenetic approach to biomanufacturing is set to make waves thanks to the achievement of an impressive milestone in monoclonal antibody (mAb) manufacturing.
Now, alongside a recent emerging technology designation from the FDA and mounting interest in its platform from industry heavyweights, Prolific is increasingly well positioned as its light-controlled production method takes steps into the spotlight.
Leveraging its bespoke Photomolecular platform—which Prolific has designed to use light and optogenetics to “directly and dynamically” manipulate gene expression in living cells—the company on Tuesday announced that it has reached a record-breaking productivity milestone of 21 g/L in a 15-day intensified fed-batch Chinese hamster ovary (CHO) cell line run for a mAb.
That tracks significantly above the industry standard of below 10 g/L and, in Prolific’s estimation, the accomplishment puts it on track to achieve a manufacturing yield goal of 25 g/L in fed-batch by year’s end, according to an April 5 press release.
Prolific CEO and co-founder Deniz Kent, Ph.D., said his company wants to spread the technology across the biopharma ecosystem. The company figures that its approach could potentially offer a step change in traditional biomanufacturing methods by equipping developers with “precise, real-time control over when and how much protein a cell produces,” according to its announcement.
By contrast, cells today are primarily controlled via genetic systems that are “always on,” or molecular approaches, which, “once you add, you can't remove and you can't dynamically change,” Kent explained in a recent interview with Fierce.
Beyond increasing efficiency in mAb manufacturing, Prolific’s luminescent approach could also address key developability and low-yield challenges that potentially threaten the commercial viability of next-generation complex biologics, according to the company.
Aside from the scale of Prolific’s yield, the company noted that its platform’s mAb run maintained roughly 87% viability at harvest, with a peak viable cell density of 33 million cells/mL. The run further sustained a specific productivity of around 60 pg/cell/day.
In essence, Prolific’s platform is a toolkit that allows processes inside of cells to be selectively controlled with light, combining synthetic biology, hardware and software, Kent said.
“Our technology is basically like this Rosetta Stone that converts digital inputs like electricity and light into biological inputs, which are biochemical cascades,” Kent explained.
In the long term, his company's goal is to build a “translation layer" between machines and cells so that AI algorithms can be used to control cells in biomanufacturing.
Kent added that at present, Prolific is using “one color of light to control one process: transcription,” adding that the “ultimate goal is to have multiple different colors of light controlling multiple different processes.”
It’s at that point that Kent figures Prolific will reach the “limit of productivity,” which he estimated could be on the order of 40 or 50 grams per liter.
Prolific’s approach revolves around light-sensitive proteins, the illumination systems, which Prolific uses to activate certain metabolic pathways, and the company's AI-powered smart control system, which is designed to monitor and adjust illumination in real time.
Kent described the platform's hardware piece as “plug-and-play” with companies’ existing infrastructure. “We just send a team of engineers, they put some illuminators into your existing bioreactors, and suddenly you’ve tripled your yields,” he said.
In essence, “we’re building the world’s first driverless bioreactors,” Kent added. “Intelligent machines can control biomanufacturing for the first time using light.”
Beyond monoclonal antibodies, Kent figures Prolific’s platform could present even greater opportunities for more complex molecules, such as multispecifics, cytokines and fusion proteins.
As for how Prolific aims to leverage its platform in the commercial realm, Kent noted that “we want to make this accessible to everyone in the ecosystem,” adding, “we’re not keeping this to ourselves.”
While Prolific can’t discuss specifics at this time, the company’s platform has already garnered the attention of major CDMOs and branded drugmakers alike, per Kent.
Founded in the Bay Area in 2020, Prolific was able to secure a $55 million series B financing round back in mid-2024, led by the Ki Tua Fund, with support from the likes of Breakthrough Energy Ventures, Mayfield, SOSV, Shorewind Capital and Darco Capital.
Meanwhile, in another sign of the company's growing recognition, Prolific was added to the FDA's Emerging Technology Program last May, which falls under the Center for Drug Evaluation and Research. The program is designed to help smooth out the regulator process for developers of innovative manufacturing approaches through collaboration with the agency.