Biologics manufacturing by high-density microbial fermentation has advantages of development speed, low cost, and scalability.
KBI's approach is the best fit when selecting E. coli as the preferred host for expression of non-glycosylated proteins, including both soluble and insoluble product accumulation including downstream capture, host-cell impurity clearance, and, where necessary, controlled and scalable refolding. KBI also has experience with various non-E. Coli bacterial hosts such as Pseudomonas-based and third-party proprietary expression systems.
In cases of insoluble protein accumulation in inclusion bodies (IBs), KBI develops high-yielding recovery processes with analytical characterization of conversion to an active product by solubilization and refolding techniques. KBI's unique expertise in this area has enabled the use of microbial hosts for the expression of several known "difficult-to-refold" products at a favorable scale and cost.
KBI applies proven, well-characterized microbial recombinant protein expression systems to provide state-of-the-art, early-stage/preclinical through cGMP services, including:
Off-the-shelf and engineered E. coli strain evaluations:
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