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Microbial
Fermentation Manufacturing

We offer extensive development and manufacturing services using microbial expression biologics systems

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Mammalian          Microbial        pDNA        Viral Vector        Cell Therapy        mRNA

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.

Microbial Manufacturing and Production

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.

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Microbial Expression 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.

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Microbial Manufacturing Scales

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.

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Microbial Manufacturing Track Record

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Years of experience

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Commercial microbial products

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Microbial processes & products produced

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Microbial Drug Manufacturing Trends Driving the Future

Access this white paper to discover the changes affecting the microbial manufacturing industry.

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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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Large-scale fermenter bioreactor for microbial manufacturing.

Microbial Development from Clinical to Commercial

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Cell Line Development

Focused on the industry’s most popular microbial expression platforms.

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E. Coli and P. Pastoris

The ability to optimize media feeds and standard processes for high cell density E. coli and P. pastoris production.

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Process Development

Enhanced upstream process, reliable chromatography for purification, endotoxin and host cell protein removal, and high cell density fermentation.

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Analytical Development

Established robust in-house analytical methods utilizing state-of-the-art techniques to guarantee accurate and reliable characterization.

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Process Development Fact Sheet

Our extensive experience enables us to replicate existing processes or develop a customized approach, depending on your needs.

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Locations Offering Microbial Services


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