AGC Biologics doubles mammalian capacity
Contract Development and Manufacturing Organisations (CDMOs) are playing an increasingly critical role in the large molecule drug market.
The biopharmaceutical CDMO market continues to grow in double digits annually. With scientific ability and ingenuity, the latest technology, and copious manufacturing capacity, these partners are now critical to the ecosystem. A notable example of this is AGC Biologics, one of the fastest-growing CDMOs in the life sciences space. In the last few years, the company has expanded at sites in Japan, USA, Germany, and Italy.
The CDMO is also finishing one of the biologics industry’s most extensive expansion projects, a new building at its site in Copenhagen, Denmark that is offering developers greater access to large-scale mammalian cell-culture development and manufacturing services.
AGC Biologics Copenhagen site
The Denmark-based site is one of the most active biologics facilities in the AGC Biologics network.
AGC Biologics runs multiple mammalian and microbial cGMP manufacturing lines at various scales and offers technological flexibility to meet drug product specifications.
The site’s core teams of scientists have been working together to develop and manufacture biologics for more than 20 years. The facility is truly one of the top CDMO sites in Medicon Valley and is ready to take on more projects.
Mammalian capacity expansion
AGC Biologics invested in an expansion and a new dedicated building to extend the Copenhagen site’s capabilities and more than double its single-use bioreactor mammalian cell-culture capacity.
AGC Biologics is actively having discussions to fill this space now, with operations beginning in mid-2023.
This expansion is a clear demonstration of AGC Biologics’ commitment and dedication to supplying innovative technological manufacturing solutions for developers and large pharmaceutical companies. The new building will include four levels holding about 8,000 m2 distributed across manufacturing, quality control laboratories and technical and warehouse areas. The production will be focused on genetically modified organisms, biosafety level 1, and manufactured using single-use technology in dedicated cleanrooms.
Global supply chain access
In addition to expanded capacity, one of the other benefits of working with a global CDMO is access to a greater network of supplies. The challenge of finding affordable supplies has grown larger because of the COVID-19 pandemic and now again with potential financial market inflation. The longer it takes to secure supplies for pharmaceutical development, the longer it takes to get products to patients. For developers and pharma companies of all sizes, this can be the difference between being first to market or falling behind your competitors.
A CDMO like AGC Biologics has extensive material sourcing abilities, effective bargaining power, and worldwide inventory and supplies. This network of shared resources gives AGC Biologics more buying power and the ability to lower the total cost of goods to produce a drug product. The global supply function can also stand up to supply market changes – even during a pandemic or global economic strain.
With this deep supply chain and the knowledge and experience of the scientific team at each site, AGC Biologics can help resolve any issues during the development and manufacturing process and effectively guide the product through important clinical and commercial deadlines.
Sites in Europe, Japan, and USA
If you need something done outside of Copenhagen or the European continent, AGC Biologics’ seven sites have a range of specialisations, scales, and capabilities.
In addition to traditional biologics (mammalian and microbial), the CDMO specialises in recombinant DNA, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.
Heidelberg, Germany: The Heidelberg facility serves as a hub for microbial systems and services for AGC
Biologics’ global customers. The site has scientists with several decades of protein expression experience, which enabled AGC Biologics to set up a centre for custom pDNA and mRNA service lines at this site.
The facility’s segregated line design allows for capacity and technological flexibility while ensuring compliance with current global guidelines needed for cGMP compliance.
Milan, Italy: AGC Biologics Milan specialises in cell therapy and viral vector development and manufacturing. The site works with any cell type and lentiviral, retroviral, and adeno-associated viral vectors. The facility was the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies. The core scientific team has 25 years of experience in the field and unique knowledge you will not find anywhere else.
Chiba, Japan: This multipurpose, highly efficient facility is one of the few sites in Japan with both microbial and mammalian capabilities, backed by a global CDMO network. The facility’s core structure and gravity-based design enable guaranteed flexibility and high-quality work. The Chiba teams have experience in cGMP microbial manufacturing for many projects, ranging from E. coli to yeasts, while the site's mammalian offering guarantees ability and technological flexibility, thanks to the extensive adoption of single-use systems.
Boulder, Colorado, USA: The AGC Biologics Boulder Facility offers a significantly larger production scale for mammalian-based projects. The site houses two massive stainless steel cell bioreactors, and its size, automation, and cost-effective capabilities make it well-suited for high-volume commercial production and high titer antibody processes. In addition to cGMP commercial services, the site has a stellar record in cell line development and experience with multiple mammalian cell types and expression systems.
Longmont, Colorado, USA: Longmont is AGC Biologics’ North American Hub for cell and gene therapy services. The site's capabilities include viral vector development, characterisation, and manufacturing in adherent and suspension environments, along with cell culture and modification development and manufacturing using the latest industry technologies and methodologies.
Seattle, Washington, USA: The campus is the headquarters and has been producing biologics products for 30 years. Here, AGC Biologics operates multiple manufacturing lines and a variety of scales for mammalian and microbial biologics. With a uni-flow design, the campus offers capacity and technological flexibility, including extensive adoption of single-use systems, while ensuring compliance with current ICH guidelines required for cGMP compliance. This location is the company's center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes.
This article was originally published in European Biotechnology Magazine Winter Edition 2022.