The Massachusetts-based biotech is developing synthetic live bacterial therapeutics using tools and components including a proprietary library of synthetic biology parts. As Synlogic is manufacturing live bacteria, its production process differs from those used to make traditional biologics.
Synlogic invested in its internal capabilities to handle the novel modality, establishing both lab-scale production capabilities to support its early-stage work and fermentation, downstream harvesting and lyophilisation capacities to enable the production of materials for early and mid-phase clinical trials.
Now, with its co-lead candidates closing in on the start of late-stage development, Synlogic is again investing in its in-house capabilities to ensure it has the means to support the advancement of its pipeline.
“By building a fully integrated internal process development and manufacturing infrastructure, Synlogic will be able to respond quickly to the needs of our clinical program and ensure the rapid progress of our pipeline. Completion of the build out this year sets us up for a rapid transition to late-stage development of our metabolic portfolio after potential proof-of-concept readouts in the second half of 2021,” said Aoife Brennan, CEO of Synlogic, on a May 13 quarterly results conference call with investors.
Additional fermentation and lyophilisation capacity
The construction and build out of additional fermentation and lyophilisation capacity, which is set to take place in the second half of 2021, will equip Synlogic to produce larger volumes of SYNB1618 and SYNB8802.