Da Yu Protein Sciences – Biologics
E. coli is the production host for most heterologous recombinant aglycosylated proteins marketed for therapeutic use including interleukins, interferons, growth hormone, insulin and granulocyte colony stimulating factor (G-CSF). The advantages of using E. coli as a production system for these Biologics are many, some of which include the following:
- E. coli is well known to regulatory agencies.
- Large-scale fermentations are economically more favorable compared to mammalian cell culture.
- There is significant understanding of E. coli physiology and metabolism for optimizing growth and protein production.
- E. coli is amenable to genetic manipulations facilitating the creation of new strains with desirable properties.
The Biologics market continues to grow and evolve. E. coli expression systems will continue to play a significant role in Biologics development. The adaptability of this prokaryotic expression system is often the best approach for producing novel and designed therapeutic proteins such as scFv and multi-functional fusion proteins. Perseus™ Expression Technology epitomizes the adaptability of E. coli for protein expression. Based on empirical studies for individual proteins, Perseus™ Expression Technology can offer the potential of producing designed proteins in a soluble form that is scalable to levels supporting commercial manufacturing.
Biosimilars - Many marketed therapeutic proteins produced in E. coli have now exhausted their patent protection and are the target of competition by Biosimilars in development. Numerous companies are pursuing a finite number of therapeutic proteins as Biosimilars; offering limited ability for differentiation in the market. However, many of these marketed therapeutic proteins are produced in E. coli as insoluble inclusion bodies, which is the notable disadvantage of E. coli expression. Protein production in inclusion bodies is costly because it requires large-scale solubilization and refolding that can result in low protein yields. Biosimilar manufacturers who can avoid inclusion body formation may have an economical competitive advantage in the market. Perseus™ Expression Technology offers Biosimilar manufacturers the potential to minimize inclusion body formation and significantly reduce manufacturing costs, which can then provide cost differentiation in the Biosimilars market.
Da Yu Protein Sciences has extensive experience in E. coli protein expression from strain selection to growth conditions. We have assembled a collection of proprietary expression plasmids created specifically for Biologics. For more information on our Biologics production services or to discuss Perseus™ Expression Technology for your innovative protein or Biosimilar please Contact Us.