We offer extensive development and manufacturing services using microbial expression biologics systems
CDMO Microbial Services
Our best-in-class cell line and process development services offer a comprehensive range of capabilities to meet your specific product needs.
We have produced 100+ products using microbial-expressed proteins and multiple modes of expression - including secretion (yeast), periplasmic secretion, soluble intracellular expression, and inclusion bodies. The AGC Biologics network has produced eight commercial products using microbial systems.
Our microbial services range from cell-line development and process development to clinical and commercial manufacturing. Our expertise includes experience with E. coli, Pichia pastoris with or without methanol induction, Pseudomonas Fluorescens (PFEnex system), Bacillus (non-sporulating), L. casei, and more.
We offer flexible manufacturing scales up to 3,000 L and our cell banking services meet the standards of regulatory agencies around the world. We use standard industry systems, including batch and fed-batch methods, to produce microbial drug products.
Microbial Manufacturing Track Record
Years of experience
Commercial microbial products
Microbial processes & products produced
Microbial Fermentation Development
Our capabilities include methanol feeding, oxygen enrichment, continuous centrifugation, and high-pressure homogenization capabilities, ensuring the highest quality and efficiency throughout the manufacturing process. Our cGMP-compliant systems utilize stainless steel fermenters at various scales. Whether you require small-scale production or large-scale manufacturing, our facilities are tailored to deliver optimal results for your microbial-based products.
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Microbial Development from Clinical to Commercial
Cell Line Development
Focused on the industry’s most popular microbial expression platforms.
E. Coli and P. Pastoris
The ability to optimize media feeds and standard processes for high cell density E. coli and P. pastoris production.
Enhanced upstream process, reliable chromatography for purification, endotoxin and host cell protein removal, and high cell density fermentation.
Established robust in-house analytical methods utilizing state-of-the-art techniques to guarantee accurate and reliable characterization.