Microbial fermentation has been used in many industries, including medicine, food, energy, chemical industry, agriculture, etc. Process scale-up is a necessary link for fermentation from experimental research to industrial production. 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. cGMP manufacture of engineered bacterial therapeutics can benefit the health industry. Our licensed facilities are prepared to meet the associated downstream processing and purification in cGMP.
- Different live organisms (aerobic and anaerobic bacteria, yeast)
- Batch and continuous sterilization of media
- Dedicated facility for cell bank preparation and storage with redundant equipment and controls
- Fully instrumented fermentation suite to avoid batch to batch differences
- GMP capacity with a strictly sterile workstation 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 (microfiltration - chromatography, centrifugation - crystallization, liquid / liquid extraction - fluid bed drying, ultrafiltration - filter drying, evaporation)
- 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
