In 2025, biopharmaceutical developers faced a familiar set of contradictions: the need to move faster against tightening capital constraints, and the demand to manufacture increasingly complex molecules with limited internal infrastructure. For AGC Biologics, this year was defined by fitting facilities to these evolving processes, providing the technical depth to handle difficult projects while offering the flexibility required by lean biotech teams.
From expanding single-use manufacturing capacity in Asia to securing commercial paths for rare cell and gene therapies for patients across the globe, we focused on delivering the technical resources and partnership models necessary to bridge the gap between clinical milestones and commercial reality.
Managing Complexity: Cell & Gene and Advanced Modalities
The industry saw a shift toward more intricate therapeutic modalities, and AGC Biologics’ cell therapy and viral vector divisions responded by taking on projects that others might deem too risky or complex.
A standout collaboration in 2025 was with AAVantgarde, where we were selected to manufacture dual-vector AAV gene therapies for inherited retinal disorders. This project addresses a specific technical hurdle: therapeutic genes that are too large for a standard AAV vector. By leveraging the BravoAAV™ platform, our Milan facility is manufacturing two vectors that reassemble within the target cell, a process requiring precise control and deep viral vector expertise.
Similarly, the partnership with Rarity PBC highlighted our ability to support commercial-stage gene therapies. We are providing the commercial manufacturing infrastructure for Rarity’s ADA-SCID gene therapy, a treatment for "Bubble Baby Disease." This agreement aims to provide the first commercial path for this life-saving therapy in the U.S.
Beyond viral vectors, we expanded our work in mRNA through a partnership with Repair Biotechnologies. This collaboration focuses on a novel mRNA therapy designed to reverse atherosclerosis by breaking down toxic cholesterol in cells, moving mRNA application beyond infectious diseases into chronic condition management.
Building Infrastructure for Flexibility
With manufacturing capacity now more accessible across the industry, our 2025 infrastructure investments prioritized scientific expertise and flexibility. We focused on building a global network capable of fitting the facility to the process, allowing partners to access the right technology in the right geography.
In Yokohama, we announced the installation of two 5,000 L Single-Use Bioreactors (SUBs). This expansion places large-scale single-use manufacturing on three continents to place capacity close to key markets in Asia, Europe, and North America, allowing the site to support late-phase and commercial mammalian projects starting in 2027. This addition aligns with the site’s expansion into cell therapy process development, alongside new LNP technology for mRNA projects, establishing a true regional hub for advanced therapies in the Japanese market
In Heidelberg, the focus returned to our roots in microbial fermentation. Recognizing a market shortage in large-scale microbial capacity, we launched an expansion to offer 10,000 L GMP production. This investment strengthens a site already trusted by partners like Valneva, who selected Heidelberg to support the clinical supply of their Shigella vaccine candidate, relying on our ability to guide complex molecules through clinical stages.
Technological expansion also played a key role. The partnership with ATUM integrated the Leap-In Transposase® platform into our Cell Line Development (CLD) services. This transposase-based technology inserts DNA into a host cell’s genome more stably than traditional methods, reducing development timelines by an average of three months while also increasing the titers for drug substance produced, a critical advantage for timeline-driven developers. This platform complements our historic expertise in building processes for complex, atypical molecules, such as bi- and tri-specific antibodies. It enhances our ability to help these difficult-to-manufacture products navigate the path from early clinical stages to commercial approval.
Supporting the Biosimilar Surge
Market analysis indicates the U.S. biosimilar sector is experiencing sustained growth, driving a critical need for reliable manufacturing capacity. To address this demand, we marked a major milestone at our Copenhagen campus by operationalizing a new four-story manufacturing building.
Authorized by the Danish Medicines Agency, this facility that came online in 2024 doubles our local mammalian capacity with a production line featuring eight 2,000 L bioreactors. Crucially, the site received U.S. FDA approval to begin manufacturing a commercial biosimilar product ,demonstrating our readiness and abilities to support global biosimilar developers with high-quality GMP material for international markets.
Operational Excellence and Quality
Regulatory track records are the primary metric for risk-averse decision-makers. The Seattle facility delivered a benchmark performance in 2025, completing a U.S. FDA routine surveillance inspection and ISO 45001/14001 certification audits with zero findings.
This operational rigor supported regulatory product approvals in ten different countries, including the U.S., EU, and China. It also facilitated the partnership with Novelty Nobility, a South Korean biotech developing bispecific antibodies. The project utilizes a multi-site approach, starting with CLD in Copenhagen and moving to Chiba for manufacturing, demonstrating how global quality standards enable seamless tech transfer across regions.
Looking Ahead
As 2026 approaches, the market demands CDMOs that are more than just capacity providers. They must be strategic technical partners who can de-risk the journey from the bench to the patient. With a strengthened network in the U.S., Europe, and Asia, and a proven track record in cell and gene therapies and protein-based therapeutics, AGC Biologics is equipped to help partners navigate the complexities of modern drug development.
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