Live Biotherapeutics Drug Discovery

Live biotherapeutics are a revolutionary new class of medicines that contain a live microorganism and apply to the prevention, treatment, or cure of human diseases. With the advances in microbiota and microbiome science, increasing interest has been devoted to the discovery of live biotherapeutics drugs. Equipped with state-of-the-art technology, industry-leading expertise, and years of industry experience in drug discovery, Creative Biolabs has explored a live biotherapeutics discovery platform for the product development, pre-clinical studies, and cGMP manufacturing of live biotherapeutics drugs.

Live Biotherapeutics Drugs

Live biotherapeutics drugs usually refer to next-generation probiotics (NGPs) or live biotherapeutic products (LBPs) in the context of a new regulatory framework. They are characterized by the following properties: 1) containing live microorganisms, such as bacteria or yeast, that can be naturally occurring, recombinant, or clonally selected; 2) having an intended therapeutic or preventive effect in humans diseases; 3) is not a vaccine. In recent decades, LBPs have shown great promise for reducing infection, stimulating innate immune responses, and modulating gastrointestinal metabolism.

Host-Microbiota Interaction and Live Biotherapeutics

  • Human Microbiome
  • Human microbiome means the whole community that is consisted of trillions of microorganisms that exist in a beneficial and symbiotic relationship with all of us. These bacteria sense and respond to the environment, communicate, and continuously interact with host bodies to maintain a dynamic balance. Once the balance is broken, the host body will suffer some indications.

  • Live Biotherapeutics
  • LBPs and probiotics can re-establish the necessary balance between the microbiome and its host in several pathologies. These new agents function through modulating and augmenting the microbiome for beneficial or therapeutic effect. Therefore, they are more safe, convenient, and effective. The design and construction of engineered live biotherapeutics targeting a range of human clinical applications are rapidly evolving.

Live Biotherapeutics Drug Discovery

Graphical pathway for live biotherapeutic products development.Fig.1 Graphical pathway for live biotherapeutic products development. (O'Toole, 2017)

Next-Generation Probiotics (NGPs)

With the development of analytical methods, such as the next-generation sequencing and bioinformatics platforms, many potential NGPs have been discovered or currently under intensive development. Our product portfolio extends from aerobic bacteria to anaerobic bacteria, depending on your research-tailored demands.

Diseases Linked to NGPs

Under healthy conditions, dynamic interactions exist between the host cells and the vast diversity of microbiota microbes to keep a balance. Once the situation of microbiota dysbiosis, lots of diseases will be developed, especially chronic inflammation-related diseases, such as metabolic syndromes, cardiovascular disorders, inflammatory bowel diseases, neuropsychiatric diseases, asthma, and cancers, etc.

Why Us?

  • Full range of live biotherapeutics drug discovery services, including strain identification and validation, analytical development and qualification, GMP manufacturing, cell bank creation and storage, fermentation, lyophilization, etc.
  • GMP capacity with a strictly sterile workstation equipped with internal HEPA filtration to avoid contamination.
  • Experience in conducting different live organisms (aerobic and anaerobic bacteria, yeast).
  • Licensed facilities prepared to meet preclinical to marketed production needs.
  • Continuous optimization for the GMP manufacturing and associated downstream processing and purification.
  • Experts in the field with extensive product and clinical development, manufacturing, and commercialization of live biotherapeutics and probiotics.

LBPs represent a revolutionary approach to the prevention and treatment of human diseases. Creative Biolabs has abundant experience in LBPs discovery to help our customers accelerate live biotherapeutics projects. We will work with you at all stages of the LBPs development process from the initiation of your project to the large-scale production of your microbes.

If you are interested in our services, please feel free to contact us.

Reference

  1. O'Toole, P. W.; et al. Next-generation probiotics: the spectrum from probiotics to live biotherapeutics. Nature microbiology. 2017, 2(5): 1-6.

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

Live Biotherapeutics Drug Discovery

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

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