cGMP E. coli Fermentation

Microbial fermentation is the basis for the production of a wide variety of pharmaceutical drugs and biologics, from anti-cancer drugs and vaccines to hormonal disorder therapies and many others. Over the past 10 years, more half of the 150 recombinant pharmaceutical products approved for human use by the US Food and Drug Administration and The European Medicines Agency were manufactured via microbial fermentation.

Figure 1 E. coli

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. Furthermore, the manufacture and purification of protein-based therapeutics have an extensive regulatory and commercial track record.

We offer comprehensive services in the design, optimization, scale-up and GMP manufacturing of products based on all production strategies using E.coli: soluble cytoplasmic, soluble periplasmic and inclusion bodies. Our cGMP E. coli production services include:

• Master and working cell banking services from cell line production to cryogenic storage.
• Fermentation batch/fed-batch and perfusion, up to 300L with a second 300L vessel.
• Single use/disposable systems supply you the higher quality and more flexible services.
• Downstream purification technologies including homogenization, continuous centrifugation, filtration systems and chromatography purification systems.

Our Capacity

We have developed an E. coli production platform for a variety of GMP products, allowing for easier data interpretation and earlier availability of optimized methods.

  GMP Plasmids

Highly scalable manufacturing from gram to kg quantities of plasmid for use as DNA vaccines, non-viral gene therapy or starting material for viral vector production.

  GMP Proteins

Significant experience in the production and purification of recombinant proteins for human use to match your needs.

  GMP Conjugates

Experience in coupling peptides, proteins, polysaccharides and PEG to form recombinant proteins for human use with numerous strategies (e.g. half-life extension by PEGylation, chemical conjugation).

Creative Biogene has extensive experience and considerable expertise in the use of E. coli in the manufacture of recombinant proteins, whole-cell vaccines, viral vaccines, and live biotherapeutics. We utilizes licensed processes and technologies operating to international Current Good Manufacturing Practices (cGMP) standards that provide comprehensive solutions for both biological and small molecule drugs. By adopting cGMP fermentation procedures, We have built quality into every stage of the manufacturing process, ensuring that regulatory requirements are met in terms of safety, product identity, quality and purity, and can provide batches of cGMP material produced in a range of microbial expression systems.

If you are interested in our services, please contact us for more details.