Microbiome Therapeutics

microbiome

What is the Microbiome ?

Human Microbiome

At Biose Industrie we truly believe that our health can benefit from a collaboration between human cells and microbes.

Described by Nobel laureate Joshua Lederberg in 2001, when the study of the microbiome was in its infancy, the Human Microbiome is “the ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space and have been all but ignored as determinants of health and disease.”

“The ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space and have been all but ignored as determinants of health and disease.”

The Human Microbiome is often referred to as the forgotten organ and can weigh anything from 1 to 3 kg which is effectively as much, if not more, than the human brain.

The most active and diverse area of the Human Microbiome is the gut microbiota. Here there is a mutualistic or symbiotic relationship and a harmless co-existance. There are up to and possibly even more than 1,000 bacterial species in the human gut that encode over 5 million genes.

Human Microbiome

Human Microbiota

The Human Microbiota is the combination of all the microorganisms, namely bacteria, archaea, fungi, protists and viruses or phages, that inhabit our body and that make up this complex ecological system.
They outnumber our human cells by ten to one and play an important role in how we function. Many fascinating studies have been conducted and their remarkable results go to show how the microbiota can both improve our health and prevent and cure illness.
Recent advances in DNA-based analysis through RNA, protein and metagenomic studies have enabled us to isolate and better understand these species and their numerous strains and in doing so, how they influence and affect our bodies.
Although there are thousands of different species of bacteria in or on our body, each strain is generally unique to a specific individual.

Human Microbiota
Human

Human Microbiome and Health

Unique to each and every one of us, the Human Microbiome comprises a population of thousands of microorganisms living harmoniously with our body which shelters them. Resilient by nature, this microbiota is constantly seeking its equilibrium.
It plays a major defensive role by strengthening the mucous membranes of the gut and interacting with our immune system through the production of a host of different metabolites that have a huge influence on our health.

It is also responsible for producing essential vitamins, regulating our glucose levels and metabolism, protecting us against disease causing microbes and producing neurotransmitters that communicate with our brain.

Immunology

The gut is home to most of our immune cells, meaning that there is a constant communication between them and our microbiome. A breakdown in this communication results in microbial dysbiosis whereby the presence of non-benefical or even pathogenic bacteria outnumbers that of beneficial bacteria. Diabetes, allergies, depression, IBS, certain cancers and also skin disease (atopic dermatitis and psoriasis) have all been shown to be linked to the disruptive presence of certain pathogens brought about by this imbalance. It is this very same imbalance which can often cause inflammation exposing the intestinal wall to increased permeability. This condition is known as leaky gut which is also associated with Crohn’s disease and Celiac disease.

Gut-brain axis

The brain and the gut are directly linked via the vagus nerve which means that microbes produce neurotransmitters, chemical messengers, that communicate with the brain. An example is gamma-aminobutyric acid (GABA) which is thought to play a major role in controlling nerve cell hyperactivity. Another example is serotonin which plays several roles in body functions, including influencing learning, memory and happiness. Consequently, health conditions such as mood disorders, depression, Parkinson’s disease and autism have been linked to low serotonin levels thanks to studies with mice to show the influence of gut microbes on this neurotransmitter.

Below is a non-exhaustive list of diseases which could be cured using microbiome therapeutics:

  • Cancer
  • Invasive pneumococcal disease (IBD)
  • Irritable bowel syndrome (IBS)
  • Celiac disease
  • Crohn’s disease
  • Systemic lupus erythematosus (SLE)
  • Rhumatoid arthritis
  • Obesity
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Hypertension
  • Atherosclerosis
  • Colorectal cancer
  • Autism spectrum disorder (ASD)
  • Alzheimer’s disease
  • Depression
  • Parkinson’s disease
  • Clostridioides difficile infection (CDI)
  • Chronic kidney disease
  • Childhood allergic asthma
  • Atopic dermatitis
  • Psoriasis
  • Netherton’s syndrome
Microbiome

Everything about Microbiome Therapeutics

The Human Microbiota can be manipulated or altered using Live Biotherapeutic Products, otherwise known as LBPs.

According to the FDA guidelines an LBP is a biological product that is applicable to the prevention, treatment, or cure of a disease or condition of an individual. As the name suggests, an LBP contains live microorganisms such as bacteria. An example of an LBP could be one or more strains of bacteria administered orally to treat patients with ulcerative colitis. However, LBPs are not only about intestinal delivery, but also the skin with creams and oils, vaginal administration with creams, ovules or tablets, and more recently administration via nose or mouth.
A recombinant Live Biotherapeutic Product is an LBP composed of microorganisms that have been genetically modified through the purposeful addition, deletion, or modification of genetic material.

There are several different types of LBPs :

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Single strain ;

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Multi strain – at least two different strains made independently then brought together in a capsule or sachet ;

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Co-Culture – several strains grown together in the same bioreactor then freeze-dried into a homogenous drug substance.

We are a world leading end-to-end and full-cycle pharmaceutical CDMO and in a unique position to produce clinical and commercial drug substances and drug products to GMP pharmaceutical standards under one roof. This presents a considerable advantage in assisting our clients through clinical trials and more importantly, treating patients.