Efficacy and Safety of Microbiome-Based Therapeutics
Live biotherapeutic products (LBPs), as defined by the Food and Drug Administration (FDA) and the European Pharmacopoeia (Ph. Eur.), are a biological product that:
- contains live microorganisms, such as bacteria or yeasts;
- is applicable to the prevention, treatment or cure of a disease or condition in humans; and
- is not a vaccine, fecal microbiota transplant or gene therapy product.
To ensure the efficacy and safety of live biotherapeutics, a deeper understanding of the relationship between the microbiome and human health is required. Therapeutics based on live microorganisms often have a multifactorial mode of action (MOA) and are not intended to enter the systemic circulation and target distant organs, tissues or receptors. They interact directly with the host's local ecosystem by modulating the native microbial population, e.g. by inhibiting pathogens, modulating the activity of the mucosal immune system and / or the nervous system and by producing active molecules. All this can occur individually or simultaneously and lead to further biological effects in the host organism.
High-Performance LBPs Need High-Performance Microbiological Solutions
The identification and cultivation of strictly anaerobic bacteria or bacterial mixtures and the maintenance of anaerobic production conditions are among the biggest challenges facing companies developing LBPs. We want to ensure that biopharmaceutical companies developing microbiome-based therapies are equipped with the necessary expertise to optimize production processes and ensure the optimal safety and efficacy of live biotherapeutics.
vermicon supports pharmaceutical companies and CDMOs whenever specific microbiology expertise and technological equipment is required. We can successfully handle living organisms as well as anaerobic and spore-forming bacteria and support the market launch of microbiome-based products in all production stages, including the clinical phases.
Why Is vermicon the Right Partner?
The combination of flow cytometry and VIT® is used to differentiate between living and dead cells. Only cells with active rRNA fluoresce, which means that only active, viable cells are counted. This enables a precise statement to be made about the actual effectiveness of the product.
The VIT® and Flow VIT® analysis methods used by vermicon, as well as supplementary flow cytometric methods, detect microorganisms directly in the sample without the need for cultivation. This provides a more complete and realistic picture of the microbiological status, regardless of cultivability.
VIT® uses highly specific gene probes that bind precisely to the target sequence of the desired bacterial species. This means that every species in complex mixtures can be reliably identified and quantified - even in combination with other methods such as flow cytometry.
vermicon AG is the only company in the world to have fully transferred and standardized FISH (fluorescence in situ hybridization) to industrial applications. The specially developed VIT® technology forms the basis for numerous microbiological applications - from research and development to quality control of end products. Decades of experience and an interdisciplinary team make vermicon the leading specialist in this field.
vermicon AG's quality management is certified in accordance with the requirements and guidelines of the industry-independent and globally recognized standards GMP (Good Manufacturing Practice) and ISO 9001:2015. In this way, we guarantee the highest quality and top performance for our customers, partners and employees.
Direct microbiology
Visualization of living microorganisms and analysis of their identity, purity, stability and viability (live/dead) directly in the assay.
Advanced methods
We are the pioneers in successfully using FISH and flow cytometry for the needs of industrial microbiology. With these powerful tools, we can perform cultivation-free, rapid and highly specific analyses.
Flexible workflows
The flat company organization enables us to react quickly and effectively while complying with GMP regulations.
Customer-oriented and solution-oriented
We enjoy solving problems, so our top priority is to find the most efficient solutions for our customers. No matter what technology we use or how many hours we have to spend. You can rely on that.
Exploring the Healing Potential of Nature
Recent developments in understanding the relationship between the microbiota and its host have provided evidence for 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 promote a community that is beneficial." - Foster et al. (2017) in a study on the co-evolution between the microbiome and its host.
In addition, the environment (e.g. diet, stress factors, medication, etc.) is also an important parameter and has a major influence on the composition of the microbiota. Living biotherapeutic products exert their biological effect by influencing the local ecosystem and affecting other microorganisms and their interactions with the host, thus becoming part of the "holobiont" - an entity consisting of a host and the many other species that live in or around it and together with it form an independent ecological unit.
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