List Labs, a live biotherapeutics-focused contract development manufacturing organization (CDMO), has added 500L equipment to expand its bacterial manufacturing capacity.

Based on the increased demand for larger volume manufacturing, List Labs recently added single-use equipment including a Sartorius 500L Stedim bioreactor and a Cytiva ÄKTA Readyflux XL tangential flow filtration system to their California GMP drug manufacturing facility. The expansion, available now to customers, will significantly increase List Labs’ capabilities in bacterial therapeutic manufacturing capacity appropriate for Phase 1 and 2 clinical trials.

List Labs has successfully demonstrated their ability to grow facultative and strict anaerobes to similar cell densities and protein yields using this equipment. Single-use equipment provides several advantages for manufacturing activities: it eliminates the need for clean-in-place or sterilize-in-place processes that are required for preparation of stainless-steel reactors. Single-use equipment also reduces bioreactor turn-around time by improving the speed of manufacturing activities.

Current validated cleaning protocols ensure the risk of cross-contamination is very small, but single-use equipment further reduces the risk, offering flexibility to clients who prefer to have their therapeutics manufactured in single-use equipment.

“We are thrilled to be able to continue to support our customers with larger manufacturing capacity for their clinical supply,” said Gary Henderson, director of business development, List Labs.