The role of the microbiome in overall health and immunity against pathogens, diseases, and infection has long been known. Live biotherapeutic products (LBPs) and human microbiome-based therapeutics are being developed and studied to harness this potential and create next generation therapeutics. With end-to-end CDMO services for LBPs and a long history of expertise in this field, List Labs is at the forefront of this frontier.
Leading the industry in next generation therapeutics
The human microbiome is a collection of trillions of microbes that live in and on the human body. Research has shown that the complex microbiome plays a crucial role in many basic life processes. It encompasses many parts of the body, including the gut, skin, vagina, and mouth. Each of these sites has a different consortia of microorganisms, many of which are beneficial.
In the last 10-15 years, research has increased in various human microbiome niches so scientists can better understand the influence of the microbiome on health and disease, and explore the potential of microbiome-based therapeutics. Disruption of the microbiome has been associated with a growing number of ailments, including:
Gut DisordersNeurogenerative DiseasesInfections
Metabolic DisordersFertility IssuesDermatitis
As the characterization of the human microbiome and its link to human health has become better understood, many microorganisms have been identified that may have health benefits. The use of these microorganisms in live biotherapeutic products show great promise in clinical applications. An ever growing number of clinical trials are underway to evaluate their potential as a therapeutic for the prevention, treatment, or cure of diseases or conditions.
What are the challenges of manufacturing LBPs?
Because LBPs are composed of live organisms – whether a single bacterial species or an entire consortium – their manufacture presents unique challenges, such as:
Handling live bacteria, especially spore-formers, in a manner that prevents facility contamination
Protecting LBPs from the stomach during ingestion
Engineering gut therapy LBPs so they may be quiescently deployed but designed to “awaken” after implantation instead of passing through the system
Implementing unique chemistry, manufacturing, and control (CMC) systems and processes particular to LBPs, including differentiated facilities (see below)
List Labs’ experience in manufacturing live biotherapeutic products and our specified manufacturing facilities can help you tackle and overcome the challenges that may arise throughout your LBPs’ production life cycle.
What equipment and facilities are necessary for manufacturing live biotherapeutic products?
Many of the microorganisms identified for the production of LBPs are obligate or strict anaerobes and spore-forming organisms. These types of organisms present unique challenges: in particular, anaerobic microorganisms cannot be exposed to air and thus require expertise for handling and cultivation.
Facilities and equipment important for the cGMP manufacture of these organisms include:
Biological safety cabinets
Anaerobic workstations with internal HEPA filtration for aseptic, anaerobic fill capability
Equipment to scale the process cultivation
Stainless steel or single-use bioreactors
Closed harvest systems such as tangential flow filtration with hollow fiber membranes
Semi-automated or automated filling equipment
Freeze-drying equipment (lyophilizer)
Homogenization and milling equipment
List Labs is Your Partner for Live Biotherapeutic Products
With 45 years of LBP experience, List Labs is distinctly qualified to help you with your next microbiome project and affords the flexibility required to achieve even the strictest timelines and goals. We understand that each project is unique, and we draw from our vast experience to deliver you a custom solution that meets your needs.
Contact us today to find out how List Labs can advance your LBP Project