Microbial Commercial Manufacturing

Making Complex Applications Possible with Advanced Microbial Commercial Manufacturing for New Biologics

KBI Biopharma has extensive experience with microbial cell line development, microbial clinical manufacturing, and microbial commercial manufacturing.

The KBI Boulder facility in Colorado is our center of excellence for microbial services, including cGMP microbial commercial manufacturing. The Boulder facility includes three buildings: R&D and analytical development labs (16,000 ft²), GMP Manufacturing and QC Labs (25,000 ft²), and GMP Warehouse and QA (37,000 ft²).

KBI Biopharma has commercialized multiple microbial-expressed products within the past six years, using quality-by-design (QbD) principles to develop, qualify, and manufacture microbial-expressed biotherapeutics processes. With close ties between process and analytical groups, turn-around times for data is quick, providing near real-time analysis.

In compliance with KBI's customer-focused approach to business, our Boulder site is delivering on projects for multiple clients around the world, ranging from vaccines to monoclonal antibodies. In this facility, like across our global network, the KBI microbial commercial manufacturing services have gained a reputation for speed, quality, and versatility.

KBI has extensive expertise and experience with process commercialization and product support, including an ICH-aligned business process following a QbD-based strategy for product lifecycle management. Our strategy is executed from the earliest development stage and continues through microbial commercial manufacturing, to launch and beyond, including sustained regulatory support.

The advanced microbial commercial manufacturing process is managed through a control strategy that demonstrates and documents the process is in a state of control, and critical quality attributes (CQA) are within their targeted profiles.

Equipment

300 L and 2000 L fermentation, homogenization, centrifugation, and depth filtration for upstream processing
Refold train of 550 L, 2600 L, and 2x 2250 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 2600-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

QA Approved SOP Facility Governance

Commercial-grade 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

Cleanroom Classifications & Flows

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.

Microbial

Commercial Manufacturing