Research before and since the antibiotic era has linked the human microbiome – the large, complex community of microorganisms that reside in the gut and on the skin – with immunity against disease and general health when it is in balance. This has led to a growing field of study in the last decade among innovators exploring the potential of live biotherapeutic products (LBPs) to rebalance the microbiome and combat gastrointestinal, dermatological, neurological, and immune diseases, as well as cancers.

List Labs is at the heart of this endeavor as one of the first CDMOs to produce LBPs, driven by a team that delivers unparalleled expertise in microbiome-based therapeutics and other bacterial products. We offer process development and cGMP manufacture of products from a wide range of genera, including strict anaerobe species.

List Labs was founded in 1978 and is producing bacterially-derived products in a purpose-built, clinical-scale 26,000 sq ft facility in Campbell, California. We offer segregation and containment in seven ISO7 or ISO8 manufacturing suites for organisms up to BSL3 and spore formers, anaerobes and aerobes, and aseptic process’. The manufacturing suite design enables parallel cGMP manufacturing, which streamlines project timelines and mitigates delays.

We are executing our strategy to invest in larger-scale cGMP manufacturing to add Phase III and commercial capabilities so that clients can advance their products all the way from concept to commercial production with List Labs. Our vision is to have this integrated CDMO capability available from 2024 with a state-of-the-art, flexible, new facility.