Live biotherapeutic products (LBPs)

vermicon provides innovative technologies, specific microbiological expertise and cultivation-
independent methods for the direct analysis, quantification and visualization of microorganisms
in the assay. Our aim is to support pharmaceutical companies and CDMOs active in the
development of microbiome-based therapeutics.

 

 

 

 

Efficacy and safety of microbiome-based therapeutics

Live Biotherapeutic Products (LBPs) as defined by the Food and Drug Administration (FDA) and the European Pharmacopeia (Ph. Eur.) are a biological product that:

  • contains live microorganisms, such as bacteria or yeasts;
  • which is applicable to the prevention, treatment, or cure of a disease or condition of human beings; and
  • is not a vaccine, fecal microbiota transplant or gene therapy agent.
     

To ensure the efficacy and safety of Live Biotherapeutics, a deeper understanding of the relationship between the microbiome and the human health is needed. Therapeutics based on live microorganisms often have a multifactorial mode of action (MOA) and are not intended to reach the systemic circulation and target distant organs, tissues, or receptors. They involve in a direct interaction with the local ecosystem of the host by modulating the native microbiota, for example by inhibiting pathogens, modulating the activity of the mucosal immune system and / or the nervous system and by producing active molecules. All of those may occur individually or simultaneously, leading to further biological effects within the host.

 

Powerful LBPs need powerful microbiological solutions

Identifying and growing strictly anaerobic bacteria or bacteria mixtures and maintaining the anaerobic production conditions are among the biggest challenges that companies developing LBPs have to face. We want to ensure that biopharmaceutical companies developing microbiome-based therapies are provided with the specialized expertise they need, in order to optimize the production processes and assure the optimal safety and efficacy of live biotherapeutics.

vermicon is supporting pharmaceutical companies and CDMOs whenever a specific microbiological expertise and technological equipment is needed. We can successfully deal with live organisms, as well as anaerobic and spore-forming bacteria and support the commercial launch of microbiome-based products at all production stages, including the clinical phases.

 

Why is vermicon the right partner for you?

  • LIVE/DEAD cell detection

  • cultivation-free analysis

  • specificity

  • only experts for FISH in industrial microbiology

  • GMP certified

Our Approach

Our aim is to unlock the therapeutic potential of the microbiome through deeper understanding of the microbiota functions and the host-microbiome relationships.

Direct microbiology

Visualization of living microorganisms and analysis of their identity, purity, stability and viability (live/dead) directly in the assay.

Advanced technologies

We are the pioneers, applying FISH and flow cytometry successfully for the needs of the industrial microbiology sector. These powerful tools allow us to perform cultivation-free, rapid and highly specific analyses.

Flexible workflows

The flat company organization allows us to react swiftly and effectively, while still following GMP regulations.

Customer focused and solution driven

We enjoy solving problems, thus finding the most efficient solutions for our customers is our highest priority. No matter which technology we have to use or how many hours we have to spend. You can rely on that.

LBPs-specialized Team

We are able to work swiftly, applying agile organizational structures. This allows us to provide all of our customers with access to personal support and customized solutions.

 

Exploring nature‘s healing potentials

Recent developments in the understanding of the relationship between the microbiota and its host have provided evidence regarding the therapeutic potential of selected microorganisms to prevent or treat various diseases.

“Unlike a rainforest or river ecosystem, the microbiome is not only driven from the bottom up by species interactions, but the host is under strong natural selection to shape the microbiota from the top down and foster a community that is beneficial.” - Foster et al. (2017) in a study on the common evolution between the microbiome and its host.

Moreover, the environment (e.g., nutrition, stress factors, medications, etc.) is also an important parameter and has a large impact on the composition of the microbiota. Live Biotherapeutic Products are exerting their biological effect by influencing the local ecosystem and influencing other microorganisms and their interactions with the host, thus becoming a part of the “holobiont” - an assemblage of a host and the many other species living in or around it, which together form a discrete ecological unit.

 

Microbiome research

The human microbiome is a highly complex ecosystem. Products based on living microorganisms generally don’t work in a direct way, but interact in a multifactorial mode of action.

Probiotics

Improving the development and production process of probiotic bacteria through direct microbiology. Identity, purity, stability and viability (LIVE/DEAD) analysis directly in the sample.

Expertise and technology

vermicon supports pharmaceutical companies and developers of microbiome-based products whenever a specific microbiological expertise, technological equipment or process optimization is needed.