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.
List Labs offers a customer-focused, collaborative philosophy from our extremely experienced team. Combined with growth in our agile infrastructure — that is not locked into any single platform — we are able to offer a wide range of solutions to clients.
List Labs has a portfolio of over 100 research reagents to meet the needs of researchers, scientists, and organizations studying mechanisms of infection and disease and immune response to develop novel approaches to therapeutics and vaccines. These products are available in stock formats and volumes, or can be produced in custom volumes to meet clients’ needs.
List Labs was founded in 1978 by Dr. Linda Shoer, who was committed to benefitting the scientific community by developing high-quality products that served a need. Dr. Shoer was the only employee in the early days, after which she began hiring employees and adding equipment periodically to build the foundation for what List Labs has become today, over 40 years later.
She produced virulence factors of pathogens that allowed scientists to harness the activities of toxins and other bacterial antigens for their research and therapeutic and vaccine development. List Labs remained faithful to this scientific core and the discovery of innovative reagents, developing a catalog of over 100 bacterial agents including toxins, peptides, antibodies, and lipopolysaccharides. This laid the foundation to become a leading CDMO in bacterially-derived products, including LBPs for clinical evaluation as microbiome-based therapeutics.