AGC Biologics Launches New Cell & Gene Technology Division
AGC Biologics, a leading Contract Development and Manufacturing Organization (CDMO), has announced the launch of its new Cell and Gene Technology division, an initiative designed to further strengthen the company’s technical capabilities and reinforce its position as the most trusted and experienced advanced healthcare CDMO.
In a rapidly evolving market characterized by significant capacity but limited scientific expertise and skilled talent, AGC Biologics is taking a bold step forward. While many other cell and gene therapy CDMOs are downsizing, closing facilities, and reducing staff, AGC Biologics is expanding its presence. Its newly established “Cell and Gene Technology Division” offers unparalleled scientific expertise and development support, backed by a robust global manufacturing network that spans three strategic locations: Milan, Italy; Longmont, Colorado, USA; and Yokohama, Japan. The company also boasts proprietary cell therapy and viral vector platforms, including ProntoLVV™ and BravoAAV™, which streamline the transition to GMP manufacturing while significantly lowering costs.
At the heart of this new division is AGC Biologics’ Milan Cell & Gene Center of Excellence, a facility with three decades of experience in cell and gene therapy development. This center has secured nine commercial approvals and has an extensive track record of GMP manufacturing, producing hundreds of clinical and commercial batches. The Milan site is globally recognized for its collaborative approach, working closely with clients throughout all stages of clinical development, late-stage trials, and commercial production. It holds commercial manufacturing authorizations from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for viral vector and cell therapy products.
Over the past year, the Milan Cell & Gene Center of Excellence has experienced notable growth, obtaining FDA commercial approvals for two products—Lemmeldy™ and Aucatzyl®. Additionally, the facility achieved over 20% organic business growth in what has otherwise been a contracting market. The site has also secured contracts for commercial lentiviral vector and adeno-associated viral (AAV) vector services, autologous and allogeneic cell therapy, and new exosome projects, reinforcing its leadership position in the field.
The Milan site spans 140,000 square feet (13,000 m2) and provides end-to-end services, encompassing research and development (R&D), early development support, and clinical manufacturing. The facility includes an expansion suite capable of large-scale viral vector production up to 2,000 liters, a new cell therapy suite, and a dedicated quality control floor for comprehensive in-house testing. These capabilities ensure a seamless pathway from Investigational New Drug (IND) application through to commercialization. To date, the Milan facility has guided five viral vector products and four cell therapy products from early clinical phases to full commercialization, demonstrating its expertise in late-stage development and commercial manufacturing.
The newly formed Cell and Gene Technology division further expands AGC Biologics’ global footprint, incorporating operations at its Longmont, Colorado site and its upcoming Yokohama facility, which is set to commence cell therapy production in July 2025. With this enhanced global presence, AGC Biologics aims to accelerate the development of groundbreaking therapies while addressing region-specific manufacturing and regulatory needs.
Operating under the motto “Bring Hope to Life Together,” the new division is committed to overcoming the challenges faced in clinical-stage development. By building scalable, high-quality manufacturing processes, AGC Biologics is well-positioned to support innovative therapies and contribute to the advancement of the cell and gene therapy industry.
Luca Alberici has been appointed Executive Vice President of the Cell & Gene Technology division. Reporting to President and CEO Alberto Santagostino, Alberici will oversee the division’s strategic direction, operations, and commercial expansion. He will also continue to serve as the General Manager of the Milan Cell & Gene Center of Excellence.
“Luca is a seasoned leader with a remarkable track record of bringing cell and gene therapy (CGT) products to market,” said CEO Alberto Santagostino. “His deep industry expertise, combined with his strong leadership at our Milan facility, makes him the ideal person to guide our new division. His commitment to fostering strong client relationships perfectly embodies the ‘approachable’ culture we strive for at AGC Biologics. I have no doubt that he will maximize our resources and drive exceptional results for our customers.”
Reflecting on his new role, Alberici stated, “AGC Biologics has made significant investments to ensure that cell and gene therapy manufacturing remains economically sustainable. Our focus is on making life-saving therapies more affordable by leveraging our advanced scale and automation capabilities. We are aiming to provide lentiviral vectors for commercial use at costs as low as $1,000 per patient. With in-house quality control testing, a broad regional footprint, and expertise across multiple advanced therapy modalities, we are uniquely positioned to be the preferred partner for late-stage CGT developers.”
Alberici continued, “It is an honor to lead AGC Biologics’ cell and gene therapy initiatives. The formation of this division allows us to better serve our clients and accelerate the development of transformative therapies that bring hope to patients around the world. I look forward to collaborating with our talented team as we embark on this exciting new chapter.”
With this strategic expansion, AGC Biologics reinforces its commitment to advancing cell and gene therapies and supporting developers at every stage of the drug development lifecycle. By combining state-of-the-art technology with a collaborative, client-centric approach, AGC Biologics is poised to remain at the forefront of innovation in advanced healthcare manufacturing.
