AGC Biologics Launches Cell & Gene Technologies Division to Expand Commercial Success
AGC Biologics, a leading contract development and manufacturing organization (CDMO), has announced the formation of its new Cell and Gene Technologies Division. This strategic move aims to enhance the company’s capabilities and solidify its position as a trusted partner in the rapidly growing cell and gene therapy sector. By establishing this division, AGC Biologics reaffirms its commitment to innovation, quality, and reliability in the field of advanced therapies.
Meeting Market Demands with Expertise and Infrastructure
The global cell and gene therapy market is expanding rapidly, yet it faces challenges such as limited scientific expertise and a shortage of technically skilled operators. While some CDMOs are downsizing and shutting down facilities, AGC Biologics is taking the opposite approach by investing in its people, infrastructure, and scientific capabilities. The new Cell and Gene Technologies Division offers unparalleled support backed by a robust global development and manufacturing network, spanning three key regions: Milan, Italy; Longmont, Colorado, USA; and Yokohama, Japan.
Additionally, AGC Biologics has developed proprietary cell therapy and viral vector platforms, including ProntoLVV™ and BravoAAV™. These platforms help developers accelerate their path to Good Manufacturing Practice (GMP) phases while significantly controlling costs. This combination of technical expertise, innovative platforms, and global reach positions AGC Biologics as a premier partner for companies developing next-generation cell and gene therapies.
Milan Cell and Gene Center of Excellence: A Proven Leader
At the heart of the new division is AGC Biologics’ Milan Cell and Gene Center of Excellence. This facility boasts over 30 years of experience in the field, having produced hundreds of GMP batches and contributed to nine commercially approved therapies. Recognized as one of the most accomplished cell and gene therapy manufacturing sites globally, the Milan facility holds commercial manufacturing authorizations from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for viral vectors and cell therapies.
Over the past 12 months, the Milan facility has made significant strides, securing two FDA commercial approvals (Lenmeldy™ and Aucatzyl®) and achieving over 20% organic business growth in an otherwise declining market. The site has also expanded its service offerings, including new agreements for commercial lentiviral vector and adeno-associated viral vector services, as well as autologous and allogeneic cell therapy manufacturing and an exosome project. These achievements reinforce its standing as a top-tier CDMO for cell and gene therapies.
Advanced Manufacturing Capabilities
The Milan facility spans 140,000 square feet (13,000 m²) and provides end-to-end services. It includes research and development (R&D) teams that support initial development and early clinical phases, large-scale viral vector suites with capacities up to 2,000 liters, new cell therapy suites, and an entire floor dedicated to in-house quality control testing. These capabilities create a seamless pathway from Investigational New Drug (IND) applications to full commercialization. The facility has successfully guided five viral vectors and four cell therapy products from clinical development to commercial launch, demonstrating its expertise in late-stage and commercial-scale manufacturing.
Expanding Global Reach
AGC Biologics’ commitment to cell and gene therapy extends beyond Milan. The new Cell and Gene Technologies Division will leverage the company’s Longmont facility in the United States and the newly established Yokohama facility in Japan, set to begin cell therapy operations in July 2025. This expanded footprint ensures that AGC Biologics can meet the needs of developers across multiple geographic regions while maintaining the highest standards of quality and efficiency.
A Vision for the Future
The new Cell and Gene Technologies Division aligns with AGC Biologics’ mission to “Bring Hope to Life Together.” By working closely with therapy developers, the company aims to drive progress in cell and gene therapy manufacturing. This division offers comprehensive support throughout the development lifecycle, from early-stage research to clinical manufacturing and commercial-scale production. The goal is to build scalable manufacturing processes, address industry challenges, and create cost-effective solutions for groundbreaking therapies.
Leadership and Strategic Direction
Luca Alberici has been appointed Executive Vice President of the new division. Reporting directly to AGC Biologics’ President and CEO, Alberto Santagostino, Alberici will lead the global strategy, operations, and commercial development of the division while continuing his role as General Manager of the Milan Cell and Gene Center of Excellence.
“Luca is a veteran in this space, with a proven track record of success in launching CGT products in the market, and he has extensive leadership experience at our flagship Milan site,” said Alberto Santagostino. “With 20 years in the industry, his expertise will be invaluable as we expand our capabilities and customer pipeline in this vital therapeutic area. Even more importantly, I am impressed by the decades-long relationships he built with our clients, which perfectly underscores the ‘friendly’ spirit in which we conduct our business. I am confident he will lead the resources entrusted to him to deliver exceptional results for our customers.”
Alberici expressed his enthusiasm for his new role, emphasizing AGC Biologics’ commitment to making cell and gene therapy manufacturing economically viable. “AGC Biologics has invested significant resources to make manufacturing of cell and gene therapies economically sustainable for the market. With our newest scales, we are focused on making life-saving treatments more cost-effective and aim to be able to offer lentiviral vectors for commercial applications at a cost as low as 1,000 USD per patient.
Thanks to automation in cell therapy manufacturing, full quality control testing in-house, and a wide facility footprint in each global region, we believe we can now be the partner of choice for most late-stage CGT customers from CAR-T to viral vectors and new trailblazing modalities like exosomes,” said Alberici.
“I am honored to take on this new role and lead AGC Biologics’ cell and gene therapy efforts. This dedicated division will allow us to serve our customers better and support the development of innovative therapies that bring hope to patients worldwide. I look forward to collaborating with our talented teams as we embark on this exciting new chapter,” he added.
With the formation of the Cell and Gene Technologies Division, AGC Biologics is positioning itself at the forefront of cell and gene therapy manufacturing. By leveraging its global infrastructure, cutting-edge technologies, and a deep commitment to customer collaboration, the company aims to set new standards in the industry. As cell and gene therapies continue to revolutionize medicine, AGC Biologics remains a trusted partner for developers striving to bring transformative treatments to patients worldwide.
