LEARN ABOUT OUR protein-based biologics and advanced therapies
Mammalian Bioprocessing Systems
We have several decades of experience with mammalian-based bioprocessing production, and can support your project from cell line development through full-scale commercialization. We offer a variety of flexible single-use manufacturing scales with options for multiple configurations at our sites in the U.S., Europe, and Japan, and have large-scale commercial capabilities using stainless steel reactors at our site in Boulder, CO, USA.
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, also from initial development through full-scale. commercialization. Our expertise includes experience with E. coli, Pichia, Pseudomonas Fluorescens, Bacillus microbial expression systems, and more.
We use standard industry systems, including batch and fed-batch methods, to produce microbial drug products, and offer cell banking services that meet the standards of regulatory agencies worldwide, and flexible manufacturing scales to support any stage of your product lifecycle.
AGC Biologics’ cell therapy services support every stage of the product journey, from pre-clinical through commercialization. At our Milan and Longmont facilities, we can work with virtually any cell type – including Human Mesenchymal Stem Cells (hMSCs), Exosomes, CD34+, T-Cells, NK Cells, and more.
Using the latest autologous and allogeneic methods, we help your products meet the exact specifications for patients in a clinical or commercial setting.
AGC Biologics scientists have two decades of viral vector-based gene therapy expertise and specialize in adeno-associated viral vectors (AAV), lentiviral vectors (LVV), and retroviral vectors (RVV). Our sites in the U.S. and Italy have supported four commercial products.
Our ready-to-use platform capabilities for AAV and LVV programs are built on cell factories and bioreactors using adherent and suspension processes, designed entirely in-house.
To support your pDNA needs, AGC Biologics utilizes a customized process based on your specific plasmid and hosting system. We have extensive technical expertise in fermentation, purification, and analytics, and our highly experienced teams routinely manufacture GMP-grade pDNA materials. This work includes starting material for gene therapy, and viral vector manufacturing.
AGC Biologics leveraged its 25+ years of experience in microbial, drug substance, and pDNA manufacturing to create our Messenger RNA (mRNA) service line. We manufacture high-quality mRNA in R&D and GMP grades for some of the most demanding applications in the industry today, and offer customized process development services based on your specific mRNA and host system needs.