We offer extensive development and manufacturing services using microbial expression biologics systems.
We have produced 60 products with microbial expressed proteins using multiple modes of expression - including secretion (yeast), periplasmic secretion, soluble intracellular expression, and inclusion bodies.
AGC Biologics offers microbial services on three continents, ranging from cell-line development and process development to clinical and commercial manufacturing. Our expertise includes experience with E. coli, Pichia, Pseudomonas Fluorescens, Bacillus microbial expression systems, and more.
We offer flexible manufacturing scales up to 3,000L 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 Production and Manufacturing Services
- Cell line development focused on the industry’s most popular microbial expression platforms
- The ability to optimize media feeds and standard processes for high cell density E. coli and P. pastoris production
- Methanol feeding, oxygen enrichment, continuous centrifugation, and high-pressure homogenization capabilities
- Best-in-class process development services that include an enhanced upstream process, reliable chromatography for purification, endotoxin and host cell protein removal, and high cell density fermentation
- cGMP manufacturing systems using stainless steel fermenters at a range of scales to meet your product’s specific needs
- Robust in-house analytical methods using state-of-the-art approaches like UPLC, LC/MS, SEC, SDS-PAGE, UV, ELISA, cell-based bio assays and many more