By: Stacy Burns-Guydish, Ph.D., Senior Director, Production
The terms “Microbiome” and “live biotherapeutics” have been repeated frequently in the last few years in scientific circles. Researchers are understanding more and more about the various microbiomes in the human body and how they affect our overall health. From this research, microorganisms have been identified that may be beneficial to our health and could be used as a therapeutic, otherwise known as a live biotherapeutic products. This article explains an overview of some microbiome and live biotherapeutics basics.
What is Microbiome?
The human microbiome is the collection of trillions of microbes living in and on the human body. Scientists believe that it plays a role in many basic life processes and are important to our health. Perturbation of the microbiome has been associated with a growing number of diseases including inflammatory bowel disease, allergies, asthma, autism, and cancer.
What are some different types of human microbiomes?
Microbiomes are found, for example, in our gut, skin, vagina, and mouth. Each of these sites have a different consortia of microorganisms. Beneficial microorganisms have been identified in each of these niches. Researchers are studying the various human microbiomes to better understand their importance in health and disease.
What is a Live Biotherapeutic Product (LBP)?
A live biotherapeutic product contains a live microorganism that is used for the prevention, treatment, or cure of a disease or condition. As the characterization of the human microbiome and its link to human health has become better understood, microorganisms have been identified which may have a health benefit. The use of these microorganisms as a live biotherapeutic product in clinical application shows great promise. Several clinical trials are underway to evaluate their potential as a therapeutic.
What equipment and facilities are necessary for the production of a Live Biotherapeutic Products?
Many of the microorganisms identified for the manufacture of live biotherapeutic products are obligate or strict anaerobes and spore forming organisms. These type of organisms present unique challenges to the emerging microbiome therapeutic space. In particular, many of the microorganisms are anaerobes which cannot be exposed to air and thus expertise is required in handling and cultivating the organism. Facilities and equipment important for the cGMP manufacturing of these organisms include:
- Biological safety cabinets
- Anaerobic work stations 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, i.e. Lyophilizer
- Homogenization and milling equipment
List Labs is your partner for Live Biotherapeutic Products
List Labs has manufactured several live biotherapeutic products for phase clinical trials. With 40 years of experience, List Labs is distinctly qualified to help you with your next microbiome project and affords the flexibility required to achieve 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 we can help you!