Microbial Fermentation Services

Live biotherapeutic products (LBPs) are defined as live organisms (bacteria or yeast) designed and developed to treat, cure, or prevent multiple human indications. Due to the unique characteristics of live organisms, the development of robust fermentation and downstream processes to balance biomass production and engineered circuit expression is comparatively important. As a leader in LBPs solutions and microbial fermentation, Creative Biolabs provides the most advanced facilities, capabilities, and expertise to accelerate the development, cGMP manufacturing, and clinical application of LBPs.

Fermentation of Live Organisms

cGMP manufacture of engineered bacterial therapeutics is more difficult than traditional drug modalities because of the unique characteristics of live bacteria. Developing robust fermentation and downstream processes are essential for the generation of individual commercial probiotic strains at scale and at relatively low cost. Recently, automated parallel bioreactor systems allowing for accurate measurement and control of pH, dissolved oxygen, temperature, as well as the automated addition of nutrients and chemical inducers during growth have been developed for microbial fermentation.

Tab.1 Engineered bacterial therapeutics in clinical development. (Charbonneau, 2020)

Microbial Fermentation Services

With our state-of-the-art technology and industry-leading expertise, Creative Biolabs has an unparalleled track record in working with many different types of LBPs and providing highly complex fermentation services, from strain development through to large scale manufacturing. Our licensed facilities are prepared to meet preclinical to marketed production needs and the associated downstream processing and purification in cGMP.

• Capabilities
  • Different live organisms (aerobic and anaerobic bacteria, yeast)
  • Fully instrumented fermentation suite to avoid batch to batch differences
  • cGMP capacity with a strictly sterile workstation equipped with internal HEPA filtration to avoid contamination
  • Small-scale development projects 
  • or large-scale cGMP manufacturing (fermenters ranging from 5L to 500L)
  • Subsequent downstream processing, validation, purification, and lyophilization
  • In-process and end-product analytics with robust testing methods
  • Industrialization from feasibility to commercial scale-up manufacturing
  • Multiple media options to ensure high yield
  • Relatively cost-effective and easy to scale-up
  • Close collaboration to facilitate seamless transitions between project phases

• Why Us?
  • Flexibility - tailored strategies to meet different demands for pre-clinical, clinical, and commercial applications
  • Scalability - the strategy addresses small-scale development projects and scaled-up, clinical-grade fermentation
  • Universality - the strategy is easily adapted for the fermentation of diverse microbe strains
  • Optimization - continuous optimization development to choose the best pH, dissolved oxygen, temperature, etc.
  • Low cost - competitive price with high-quality services

Fermentation Process Optimization Services

The production level of microbial fermentation not only depends on the performance of the producing strain but also requires the best environmental conditions to fully exploit its production capacity, such as, the fermentation process and the fermentation medium. Different LBPS contain different microbes, Creative Biolabs can explore the best fermentation conditions for different strains, and develop the most appropriate optimization proposal for your products to maximize the yield level. Please click the hyperlink for more details on optimizing the service.

Microbial fermentation is the basis for the production of LBPs to promote effective live biotherapeutics. Creative Biolabs offers full fermentation services spanning many organisms, stages, industries, and production volumes. Our fermentation is commonly done at scale and relatively low cost. If you are interested in our services, please feel free to contact us.

Reference

1. Charbonneau, M. R.; et al. Developing a new class of engineered live bacterial therapeutics to treat human diseases. Nature Communications. 2020, 11(1): 1-11.

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