CAMPBELL, Calif., Jan. 24, 2023 /PRNewswire/ — List Labs, a live biotherapeutics-focused contract development manufacturing organization (CDMO), adds 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’ unique 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.
Gary Henderson, Director of Business Development commented: “We are thrilled to be able to continue to support our customers with larger manufacturing capacity for their clinical supply.”
List Labs is leveraging 40+ years of experience and extensive expertise handling and cultivating aerobic, anaerobic, and spore-forming bacteria to advance bacterial therapeutics. List Labs is a premier CDMO for development and manufacturing of bacterial-derived therapeutics. Headquartered in Campbell, CA, the site has seven ISO7 and ISO8 rated manufacturing suites providing containment and segregation of product campaigns. Our services include world class expertise in bacterial fermentation, lyophilization, protein purification, process development, analytical development, scale up, QC testing, and development of robust cGMP manufacturing processes for products used in clinical trials.
SOURCE List Biological Laboratories, Inc.