Zylidac Bio and Prolific Machines have partnered to move Prolific’s light-controlled protein production technology from laboratory development toward Good Manufacturing Practice production for clinical and commercial supply.
Both companies are based in Emeryville, California. Zylidac is a biologics contract development and manufacturing organization within the Zydus Lifesciences group.
Prolific’s platform uses light to regulate protein expression in engineered cells. It combines those cell lines with illumination equipment, artificial intelligence-based process optimization and analytical tools.
The technology is intended for biologic medicines, including multispecific antibodies, fusion proteins and cytokines, that can be difficult to produce.
Under the agreement, Zylidac will initially transfer Prolific’s process to its facility at a 50-liter scale and attempt to reproduce earlier results. The companies then plan to expand customer programs to 250 liters before moving into GMP manufacturing.
Prolific said its illumination hardware is compatible with Zylidac’s existing bioreactors, allowing the partners to use current manufacturing infrastructure without requiring customers to build new facilities.
At small scale, Prolific reported monoclonal antibody production of 21 grams per liter during a 15-day intensified fed-batch run using Chinese hamster ovary cells. It also reported up to threefold increases in protein concentration for other complex formats.
Those results have not yet been demonstrated at the larger scales outlined in the agreement.
Customer programs could begin with cell line development at Prolific and move to Zylidac for process development, scale-up, drug substance and finished-product manufacturing, filling and packaging.