cGMP Microbial Fermentation
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.
Our Fermentation Capabilities
- 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
Our Services
E. coli is a robust expression system for the production of proteins and plasmid DNA for clinical and commercial human use. Proteins can be made using a well-characterized production system that is relatively cost-effective and easy to scale-up through the fermentation of the fast-growing cells in bioreactors.
Many complex protein macromolecules, like human monoclonal antibodies require extensive post-translational modification. They can be produced in phylogenetically higher eukaryotic organisms such as yeast. Recombinant technology enables the expression of foreign gene encoding for therapeutic proteins in microbial systems, including those from human source.
Creative Biogene provides expert cGMP manufacturing using E.coli and yeasts. Our upscaling and manufacturing of customers' biotherapeutic products are compliant with the cGMP standards. From lab to pilot plant to commercial-scale microbial fermentation, we can take our products from microliters to metric tons in any of our manufacturing plants. Our manufacturing capabilities enable us to scale up the microbial fermentations we have developed in the lab with high throughput, accuracy, and purity.
If you are interested in our services, please contact us for more details.
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