Zylidac Bio and Prolific Machines have joined forces to scale a next-generation biologics manufacturing platform from early-stage development to Good Manufacturing Practice (GMP) production, aiming to boost yields and improve quality in the production of complex biologic drugs.
The partnership brings together Prolific’s light-controlled cell line technology and Zylidac’s integrated manufacturing capabilities to establish a development-to-production pathway for monoclonal antibodies and other complex biologics. Both companies are headquartered in Emeryville, California, in the San Francisco Bay Area.
Prolific’s platform uses light to regulate protein expression in engineered cell lines, giving manufacturers greater control over productivity and product quality. It combines optogenetics-enabled cell lines, illumination systems compatible with standard bioreactors, AI-driven process optimisation and advanced analytics.
The technology is designed to tackle some of the toughest challenges in biologics manufacturing, particularly the production of difficult-to-express proteins such as multispecific antibodies, fusion proteins and cytokines.
Prolific has reported a productivity milestone of 21 grams per litre in a 15-day intensified fed-batch run for a monoclonal antibody at small scale. The company has also reported up to threefold increases in titre for other complex protein formats.
Under the agreement, Zylidac Bio will initially transfer Prolific’s process to its facility at the 50-litre scale, with the goal of reproducing the company’s results. The partners then plan to advance client programmes to 250 litres before progressing to GMP manufacturing.
A key advantage is compatibility with existing manufacturing infrastructure. Prolific’s illumination hardware is designed to work with Zylidac’s current bioreactors, potentially allowing customers to adopt the technology without investing in entirely new production systems.
"After demonstrating success at development scale with industry-leading yields across mAbs and difficult-to-express proteins, the next step is scaling the technology to GMP production for clinical and commercial supply,” said Deniz Kent, Chief Executive Officer and Co-Founder of Prolific.
"We are very pleased to partner with Zylidac, with a proven team and a great new facility in immediate proximity to our labs in Emeryville. Our science and production teams can work on the same program in the same week, and our clients get a manufacturing partner that already knows the technology."
The collaboration is designed to give Prolific’s clients access to an integrated manufacturing route, from early development through commercial-scale supply.
Programmes can begin with cell line development at Prolific before moving to nearby Zylidac for process development, scale-up, drug substance and drug product manufacturing, fill-finish and packaging. The model is intended to simplify the transition from laboratory development to clinical and commercial production.
"Our teams visited each other's labs early on, and it was clear the capabilities were highly complementary," said Steve Lavezoli, Chief Commercial Officer of Zylidac.
"Prolific focuses on early-stage cell line development work, while we offer the process development, scale-up and GMP capacity required for later stages, including programs based on new expression technology like Prolific's. We built our Emeryville site to take a molecule from cell line to finished product. We're excited to be the team that takes this technology to production scale."
The partnership combines Prolific’s focus on advanced expression technology with Zylidac’s end-to-end biologics manufacturing infrastructure, positioning the companies to support programmes involving increasingly complex therapeutic proteins.