Microbial Clinical Manufacturing

KBI staff has extensive experience in therapeutic protein and enzyme development, manufacturing, and commercialization. From the earliest stage of clinical process development, we focus on processes which are robust, scalable, and commercially viable. Our key personnel have led 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, 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.

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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. Development and Preclinical activities are executed as non-GMP studies. Early Clinical Manufacturing is supported with qualified analytical test methods and Late Stage Clinical Studies are supported with validated methods and processes.

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

KBI’s Clinical Microbial Capabilities

    • 100 L and 1500 L fermentation, homogenization, centrifugation and depth filtration for upstream processing

    • Refold train of 550 L, 2600 L and 2x 2,250 L vessels

    • Buffer preparation vessels of 2x 600 L and 2x 750 L across refold and purification areas

    • Buffer hold vessels (100-L bags to 2,600-L vessels across refold and purification areas)

    • Purification train with multiple chromatography skids supporting columns of 10 to 80 cm diameter, and multiple TFF systems supporting 0.5 to 15 m2 membrane area

    • Commercial-ready facility: material and personnel flow, area qualification, cleaning, environmental monitoring, maintenance and operation of utilities

    • Process/product: raw material release, process validation, Batch Package system, deviation and CAPA management, in-process and release testing, and batch release

    • Safety and environment: general safety and hygiene, personnel safety such as lock-out and tag-out, confined space entry, etc., and segregated waste handling

    • Fermentation: Grade D cleanroom with segregated personnel and material airlocks. Fermentation area is served by the refold buffer preparation and buffer hold area. Seed preparation area is segregated from the fermentation suite and controlled as a Grade C cleanroom with a Grade B biosafety cabinet

    • Refold: Grade C cleanroom with a combined personnel/material airlock. Process connections exist between the Refold area and Fermentation and Purification areas

    • Purification: Grade C cleanroom with segregated personnel and material airlocks. Process connections exist to the Refold area. Purification bulk fill area is also Grade C with a Grade B laminar flow hood

    • Support areas are controlled, unclassified space, with segregated personnel and material flow into and out of the controlled areas

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