Overview of Live Biotherapeutic Products

The human body is the host of multiple microbial communities, and the complex interactions between the host and microorganisms have a significant impact on human health. Microbial communities in the human gut may lead to various metabolic and immune-related diseases, such as obesity, malnutrition, and inflammatory bowel disease. These discoveries of the interactions between the host and microorganisms have provided new insights for the treatment of diseases by regulating the structure and function of microbial communities, delivering microorganisms in a targeted and controlled manner to the body for disease treatment. Probiotics are living bacterial species that can survive and reproduce in the acidic environment of the stomach and have a beneficial effect on host health. During the first 100 years of discovery and application of probiotics, people only used them as food or dietary supplements. In the 21st century, people have gradually recognized the potential of microorganisms, especially bacteria, in disease treatment. At the same time, driven by omics technologies in life sciences, DNA synthesis and sequencing, gene editing, and other technologies, a new field of innovative drug development is gradually emerging, which is called live biotherapeutic products (LBP), also known as next-generation probiotics.

Definition and Development Principles of Live Biotherapeutic Products

In 2016, the Food and Drug Administration Center for Biologics Evaluation and Research of the United States released the first guidelines that clearly defined live biotherapeutic products as drugs and focused on the technical requirements for early-stage chemical manufacturing and control (CMC) of live biotherapeutic products. The guidelines define live biotherapeutic products as a type of biologically active drug with the following characteristics: (1) contains living organisms, such as bacteria; (2) is applicable to the prevention, treatment, or cure of a disease or condition of human beings; (3) is not a vaccine. The core element is to develop according to the standards of new drugs, specify indications, and conduct systemic evaluations of strain safety, pharmacokinetics, CMC, and clinical trials. In addition to some common features of biological products, researchers emphasize the research focus on live microorganisms, such as identifying the stability of strains, antibiotic sensitivity, resistance, possible transference and relocation, and product production control and stability.

Main Types of Live Biotherapeutic Products

Currently, the development of live biotherapeutic products can be classified into three types: single-strain LBPs, multi-strain LBPs, and engineered LBPs. Single-strain LBPs use natural single-strain microorganisms to produce LBPs, which have defined pharmacological efficacy and a single component. Multi-strain LBPs are composed of two or more natural bacterial strains, with more complex component and pharmacological efficacy models. With the development of synthetic biology, people have begun to focus on designing and modifying microorganisms to provide disease treatment efficacy and achieve targeted delivery and biological inhibition functions, called engineered LBPs. Compared with the above two types, engineered LBPs have advantages such as intelligent response, high expression efficiency, clear targeting, and diverse functions. These three types of LBPs have gradually shown clear clinical efficacy and application value in disease treatment. For example, single-strain LBPs Bacteroides fragilis has been reported to treat tumors, autism, epilepsy, psoriasis, and Parkinson's disease. Multi-strain LBPs SER-109, under development, can effectively treat Clostridium difficile infections (CDI). Engineered LBPs can significantly reduce the levels of phenylalanine in patients with phenylketonuria.

Live biotherapeutic products are live microbial preparations made from normal microorganisms or substances that promote microbial growth, with the advantages of high safety, efficacy, and low cost, which may become a dark horse in the future field of innovative drug development.

Creative Biolabs is confident in discovering live biotherapeutic products targeting different diseases. If you are interested in our services, please feel free to contact us.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.