cGMP Microbial Production

The KBI Boulder facility has extensive experience in generating E. coli based expression systems for high-level expression of recombinant proteins, typically using T7 expression in the BL21(DE3) strain as a platform. Following demonstration of expression in shake flasks, fermentation development typically progresses from shake flask to 15L volume in FPD to manufacturing scale of 100L and 1500L. Core expertise includes optimization of any expression strategy from cytoplasmic to periplasmic expression, as well as industry-leading insoluble expression coupled with refold process development expertise. KBI designs and implements processes according to the stage of development but always with commercial viability and product lifecycle in mind.