Zylidac Bio Partners with Prolific Machines to Scale Advanced Biologics Manufacturing

Prolific’s technology uses light to control protein expression in engineered cell lines, enabling substantial gains in productivity and product quality. The platform combines optogeneticsenabled cell lines, illumination systems compatible with standard bioreactors, AI-driven process optimization, and advanced analytics. The technology is particularly useful for difficult-toexpress proteins including multi-specific antibodies, fusion proteins, cytokines and other complex modalities. Prolific has reported a record-breaking productivity milestone of 21 g/L in a 15-day intensified fed-batch CHO run for a monoclonal antibody (mAb) at small scale, along with up to three-fold titer increases for other complex formats.

Under the agreement, Zylidac Bio will first complete a tech transfer of Prolific's process at 50liter scale to reproduce Prolific's results at the Zylidac site. The companies plan to subsequently scale client programs 250 liters, and into GMP manufacturing scale. Prolific's illumination hardware will work seamlessly with Zylidac's existing bioreactors, eliminating the need for customers to build new manufacturing infrastructure.

"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, Ph.D., Chief Executive Officer and CoFounder 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 partnership creates an end-to-end development and manufacturing pathway for Prolific’s clients, spanning early development through commercial-scale supply. Programs can start with cell line development at Prolific and move seamlessly a short distance to Zylidac for scale-up, drug substance and drug product manufacturing, fill-finish, and packaging.

"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."

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Prolific advances biologics development and manufacturing through optogenetics-enabled cell lines and biomanufacturing solutions. Its platform brings real-time, tunable control of protein expression into standard manufacturing equipment, improving yield, product quality and process control for conventional and complex biologics. The platform is portable across pharma and CDMO facilities and supports programs from early development to scalable, low-COGS manufacturing through flexible service and licensing models. Learn more at prolificmachines.com.

Zylidac is a fully integrated biologics manufacturer specializing in monoclonal antibodies, bispecific antibodies, fusion proteins and other complex biologics. From its 83,000-square-foot facility in Emeryville, California, Zylidac takes a molecule from cell line development through drug substance and drug product manufacturing, fill-finish, labeling and secondary packaging. Many team members have worked together for more than 30 years, conducting more than 40 cell bank programs and advancing more than 30 molecules into the clinic. Each Zylidac program runs at one site, under one quality system and one master services agreement, with one team responsible from start to finish. Learn more at zylidacbio.com.

Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. The group employs 30,000 people worldwide, including 1,500 scientists engaged in research and development. Zydus is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that improve lives.