By: Stacy Burns-Guydish, Ph.D., Senior Director, Microbiology

The human body is home to a vast ecosystem of microbes, called the microbiome.  Research is shedding light on the importance of the microbiome as a benefactor to our health and development.  Perturbation of the microbiome has been associated with a growing number of diseases including inflammatory bowel disease, allergies, asthma, autism, and cancer.

Microbiome Bacteria as Potential Therapy

Commensal bacteria of the microbiome are thought to be potential therapies for prevention or treatment of infections such as Clostridium difficile, acne, and bacterial vaginosis. Live biotherapeutic products (LBP) manufactured from commensal bacteria are being investigated by many companies and several clinical trials are underway.

Anaerobic Cultivation & Containment Required for Microbiome Research

Many of these commensal microorganisms for the manufacture of LBP are obligate or strict anaerobes and spore forming organisms,  presenting unique challenges to the emerging microbiome therapeutic space.  Expertise and proper equipment for anaerobic cultivation and proper containment of spore forming organisms is lacking in the industry and only a handful of contract manufacturing companies have the capabilities to perform GMP manufacturing anaerobic organisms, creating a bottleneck.

An alternative for companies is to build their own GMP facility, as Seres Therapeutics has done.  But start-ups typically do not have the funds to build their own facilities thus the CMO backlog impacts timelines.  Most CMO’s quote a wait of 9-12 months for projects to begin.  So how will these burgeoning companies meet their aggressive timelines to produce their LBP for clinical trials?

Questions to Ask Partner GMP Labs

If you are a startup, sound advice is to start conversations now with potential CMOs and find out if their capabilities align with your organism cultivation requirements and specifications.

• How many Live Biotherapeutic Products have they produced and released?
• What is their experience with anaerobes?
• Can they work with spore formers?
• What are their QC and QA capabilities and regulatory support?
• What scale production is possible?

List Labs Is well suited to Partner in GMP Microbiome Research

List Biological Laboratories, a boutique contract manufacturing company, has the expertise and infrastructure for manufacturing both obligate and strict anaerobes and spore forming organisms.  List has over 30 years’ experience cultivating anaerobic organisms.  We have produced master and working cell banks and LBP for several customers currently in Phase 1 and 2 clinical trials.  In addition, we have expertise in the development of the non-trivial required purity/bioburden assays, including USP61 and UPS62, for testing and release of these unique live microorganism products.

Contact List Labs to get your microbiome research project off the ground today.