World Class Cell Therapy & Viral Vector Development and Manufacturing Services
AGC Biologics Milan is our Cell and Gene Center of Excellence, and specializes in end-to-end cell therapy and viral vector development and manufacturing. The site works with virtually 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. This site has one of the most experienced CGT teams in the industry, with the core scientific team bringing 30+ years of expertise in the field and unique knowledge you will not find anywhere else.
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DOWNLOAD NOWCell Therapy Development & Manufacturing
Our cell therapy services can help at any stage, from initial development to full commercial supply. We have GMP manufacturing suites for cell therapy practice in one centralized location where all processes are managed. Using both autologous and allogeneic systems; our team has extensive experience with T cell, HSC / CD34, and NK cell products.
Viral Vector Development & Manufacturing
Our new standardized platforms BravoAAV™ and ProntoLVV™ offer an innovative templated approach to AAV and LVV manufacturing. With prequalified scale-down models simplifying and accelerating the path to commercialization, our Milan site can take on any project. Our team has helped bring 5 different products to market.
Global Overview
Analytical Development
Our globally aligned quality systems feature a full docket of site-specific processes, specifications, and records, with over 160 analytical tests and 95% of release testing provided in-house including sterility, RCL and adventitious agents.
Fill & Finish
We have the FC-800 O-Rabs filling machine onsite, with capabilities to fill 6R Type I glass vials and polymeric vials (e.g. COP) with a volume up to 8 mL. Max number of vials filled per batch: 1350 (MF covered). Filling speed: 500 vials/h 100% IPC, 800 vials/h without IPC.
ICMC™ fully certified across all systems:
- Service Business System
- Quality System
- Digital System
- Facilities and Equipment System
- Materials System
- Production System
- Packaging and Labeling System
- Laboratory Control System
- Commercial Readiness System
