Prolific Machines, a biotechnology firm developing optogenetics-based solutions for protein manufacturing, has been accepted into the FDA’s Emerging Technology Program, the company announced this week.
The FDA’s Center for Drug Evaluation and Research (CDER) program supports the adoption of novel manufacturing technologies with the potential to improve drug quality and availability. Prolific’s inclusion in the program marks a key step for its Photomolecular Platform, which aims to reduce costs and complexity in producing biologic therapies.
“We are honored to be accepted into the FDA’s Emerging Technology Program,” said Deniz Kent, CEO and co-founder of Prolific Machines. “This is a testament to the potential of our technology to unlock cheaper, faster, and higher quality protein production, particularly for difficult-to-produce therapeutics. We look forward to working closely with the FDA to advance our platform and make more therapies accessible to patients sooner and cheaper.”
Prolific’s platform uses light to control cellular behavior, a method the company says can enhance protein yield, consistency and quality. The company recently completed what it called the world’s largest optogenetics demonstration at a 200-liter scale in a stainless steel bioreactor.
The company believes its technology could address long-standing limitations in manufacturing complex biologics, including protein therapeutics that are often abandoned in early development. According to Prolific, up to 30% of promising drug candidates are shelved due to production challenges, while complex biologics are expected to make up as much as 40% of the development pipeline by 2030.
Tell Us What You Think!