The CDMO Zylidac Bio has partnered with biotech Prolific Machines to scale Prolific's light-controlled cell line development platform from early development through to GMP production.
Both companies are headquartered in Emeryville in the San Francisco Bay Area, with Zylidac a fully integrated biologics CDMO within the Zydus Lifesciences Limited (Zydus) group.
Prolific's platform uses light in order to control protein expression in optogenetics-enabled cell lines.
It says the technology allows for substantial gains in productivity and product quality, claiming 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.
The technology targets difficult-to-express proteins, including multi-specific antibodies, fusion proteins, cytokines and other complex modalities.
Under the agreement, Zylidac Bio will first complete a tech transfer of Prolific's process at 50-litre scale to reproduce Prolific's results at the Zylidac site.
The companies plan to subsequently scale client programmes to 250 litres and then into GMP manufacturing scale.
Prolific's illumination hardware can be used in standard bioreactors, with the companies expecting it to work "seamlessly" with Zylidac's existing bioreactors.
"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 Dr Deniz Kent, CEO 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 programme in the same week and our clients get a manufacturing partner that already knows the technology.
The partnership gives Prolific's clients an end-to-end development and manufacturing pathway spanning early development through commercial-scale supply, starting with cell line development at Prolific and moving the 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," added 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 programmes 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."
