Manufacturing Microbial-Expressed Biologics

Advanced Microbial Clinical Manufacturing of Biotherapeutics

 

KBI Biopharma has extensive experience in therapeutic protein and enzyme microbial cell line and process development, microbial clinical manufacturing, and microbial commercial manufacturing.

From the earliest stage of clinical process development, we focus on processes that are robust, scalable, and commercially viable. Our team has led key CMC projects through successful IND and BLA filings.

The KBI Boulder facility has extensive experience in generating E. coli-based expression systems for high-level expression of recombinant proteins, using our proprietary PUREcoli strain as part of the PUREplatform. Following demonstration of expression in shake flasks, fermentation development typically progresses to 15L volume to microbial clinical manufacturing scale of 300L in single use bioreactors and 2000L in stainless steel bioreactors.

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 while keeping in mind commercial viability and product lifecycle. Development and preclinical manufacturing activities are executed in non-GMP conditions. Early microbial clinical manufacturing is supported with qualified analytical test methods and late stage clinical studies are supported with validated methods and processes.

Our intentional application of phase-appropriate activities results in cost savings for early clinical phases while providing the full regulatory support necessary to set up further advancement of programs into the late stage and commercial manufacturing.

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