GMP Biomanufacturing
Production in E.coli
Escherichia coli is a robust and cost-effective expression system for the production of proteins and plasmid DNA for clinical and commercial human use.
We offer significant experience 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.
Why use Escherichia coli?
Escherichia coli is the industry standard expression system, widely used for the production of recombinant proteins and plasmid DNA.
High growth rates
E. coli offers high growth rates using simple and inexpensive fermentation media. The short manufacturing times ensure a cost-effective production approach.
Highly Scalable
Fermentation conditions are highly scalable and reproducible reducing risk and delays as the process moves through clinical trials towards commercial manufacturing.
High yields
E. coli offers high yields in a reproducible manner. The cost per gram of GMP product can be highly competitive compared to mammalian expression systems offering a commercial competitive advantage.
We produce parenteral biologics
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
More than 30 years of experience in the production and purification of recombinant proteins for human use, we are ready for your project goals.
GMP Conjugates
Experience coupling peptides, proteins, polysaccharides and PEG to proteins for use human use with numerous coupling strategies.
Regulatory
All GMP material is produced in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.