Living inside every person are trillions of microorganisms — bacteria, viruses, fungi, and other life forms collectively known as the microbiome. Novel therapeutics using living microorganisms known as live biotherapeutic products, also known as LBP, derived from the microbiome, are being developed to prevent, treat, or cure a disease or condition, such as neurodegenerative, psychiatric, and gut disorders, infertility, infections, and cancer.
A recognised expert in this field is California-based List Biological Laboratories Inc. (List Labs), a microbiome contract development and manufacturing organisation (CDMO) with a proven track record over several decades. Last year, List Labs was acquired by Genome & Company, a South Korean developer of innovative drugs and novel target immune checkpoint inhibitors. The acquisition significantly expands Genome & Company’s competence.
List Labs, together with its recently established sister company List Biotherapeutics, will provide an end-to-end development and manufacturing solution for all stages of clinical trials and commercialization for microbiome-derived live biotherapeutic products. This evolution has been supported by a major investment in a brand-new 130,000-square-foot contract manufacturing organisation (CMO) facility in the Fishers Life Science and Innovation Park in Indiana.
“Our objective with the investment for this new facility is to manufacture live biotherapeutic products for Phase 3 clinical trials and for commercial use,” said Jonathan Yongwan Jo, President of List Biotherapeutics. “With that investment, we aim to become the market leader and premier CMO to bring LBPs to market, leveraging List Lab’s 40-plus years of experience and expertise in the industry.”
Serving the Global Research Community
Founded in California in 1978 by Linda Shoer, List Labs supports biotechnology companies in the microbiome space through process development and cGMP manufacturing of live biotherapeutics for early-stage clinical trials. List Labs is also well known for its high-quality reagent-grade products and offers a catalogue of over 100 bacterial reagent products including toxins, peptides, antibodies, and lipopolysaccharides, used in medical research and vaccine development throughout the world.
Stacy Burns-Guydish, President List Labs, describes how the company developed from a one-woman business to its prominent position today: “Harnessing bacteria’s potential for a healthier world has been the purpose of the company from the very beginning, and describes not only our history but our future too.”
She explains that Linda Shoer, the company founder, manufactured the first product, cholera toxin, and then grew the business with a commitment to developing high-quality bacterial products and toxins that served a scientific need. Due to the company’s botulinum toxin expertise, List Labs assisted several commercial manufacturers, including the largest, with the development and manufacturing process for botulinum neurotoxin for aesthetic and therapeutic use.
The history of working on botulinum toxin had an unexpected benefit as well: as List Labs employees are vaccinated against the botulinum toxin, they produce antibodies which circulate in their plasma. These can be used to create a therapeutic called BabyBIG® for infants with botulism. As there are so few people vaccinated against this toxin, this puts List Labs personnel in a rare position to donate a priceless gift. “Since licensure of BabyBIG® in 2003, over 2100 infant botulism patients have been treated. “Many of our employees are active donors and we support them in their time commitment to this worthy cause,” says Stacy.
The manufacture of botulinum toxin drug product gave the company its first experience with GMP manufacturing, and ultimately, List Labs began producing its own GMP Lipopolysaccharide – a product which is the only source of GMP LPS for clinical trials. Realising that List Labs’ extensive experience with a variety of bacterial organisms could be applied to the microbiome space, the company became one of the first to manufacture a live biotherapeutic product that went into clinical trials.
The Perfect Synergy
“With List Lab’s CDMO focused on live biotherapeutics, we expanded our production capacity with a 500L single-use reactor to support clients through Phase 2 clinical trials. However, our aspiration was to provide an end-to-end solution for our clients through Phase 3 and commercial manufacturing. We saw that there was an opportunity as there was not a lot of availability for late-stage clinical manufacturing for live biotherapeutics,” says Stacy.
This synergy was found with Genome & Company. At the end of December 2021, Genome & Company bought a majority share in List Labs and invested in the expansion via the establishment of a new provisional sister company, List Biotherapeutics.
The planned investment of more than $125M in a new manufacturing facility, laboratory, and office space in the city of Fishers, Indiana, set to be commissioned by the end of 2024, will make the company one of a kind. The facility will have four process trains each with 2000L volume capacity, where List Biotherapeutics will manufacture live biotherapeutic products, and other microbiome-derived products for late-stage clinical trials.
Jonathan says: “We are wrapping up the basis of design, and also working on the engineering infrastructure to prepare for the construction.”
He explains that Fishers, Indiana is conveniently located in the vicinity of big pharma companies such as Eli Lilly, as well as CDMO companies such as Catalent. Another advantage is the proximity of universities such as Purdue University that may provide the required talent, in line with the company’s plans to eventually recruit over 200 people.
Growing to Serve
“Microbiome-derived therapeutics is a burgeoning new field that began with the use of donor-derived faecal microbial transplantation followed by the use of single live bacteria or a consortium of bacteria as a live biotherapeutic product. Companies are also now specifically targeting the proteins that elicit the therapeutic effect,” says Stacy. “List Labs has a wealth of experience purifying native bacterial proteins throughout its history so we are poised for this transition in the space too.”
Speaking about the future under the parent company, Stacy affirms that List Labs will continue to support the design of the Fishers facility in Indiana, as well as the expansion of its own workforce and capacity at the Campbell, California facility. “We are excited about increasing our Phase 1 and 2 capacities to 500L, making upgrades to our QC laboratories, and bringing innovative process and analytical equipment that will enhance our unique capabilities in the live biotherapeutic space.”
On behalf of List Bio, Jonathan describes a wider vision. “Obviously, right now, my attention is mostly focused on building the new facility in Indiana, but we are planning to grow further, both organically and by acquisition. We have a bigger dream – we want to become a global microbiome CDMO. In the future, we will expand further, possibly overseas, so that we can achieve that dream.”
