AGC Biologics, a leading contract development and manufacturing organization (CDMO), has formed a strategic partnership with clinical-stage biotechnology company Quell Therapeutics to advance multiple T-regulatory (Treg) cell therapy candidates targeting severe immune disorders. The collaboration, announced on May 15, 2025, will focus on preparing these innovative therapies for Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions.
Under the agreement, AGC Biologics will provide lentiviral vector (LVV) material using its proprietary ProntoLVV™ platform. The company's Milan Cell and Gene Center of Excellence will produce the LVV material essential for Quell's Treg cell therapy candidates.
Strategic Manufacturing Approach
The ProntoLVV platform process will integrate Quell's gene of interest into standardized production protocols with off-the-shelf starting materials. This approach offers flexibility for both suspension and adhesion systems while ensuring Good Manufacturing Practice (GMP) readiness and a smoother transition to clinical trials.
"Our ProntoLVV platform is well-suited to support Quell in advancing its Treg cell therapies toward clinical trials," said Luca Alberici, Executive Vice President, Global Cell & Gene Technologies at AGC Biologics. "By combining standardized processes with the strong technical expertise of our scientific teams at the Milan site, we will work closely with our partners at Quell to help them streamline the development of these therapies while delivering the high-quality lentiviral vector material essential for CTA/IND submissions."
The platform streamlines lentiviral vector production through standardized procedures that reduce production time while maintaining flexibility. It includes high-quality, ready-to-use packaging plasmids, a unique gene transfer system, and comprehensive documentation to support regulatory submissions. With in-house analytics and scalable production capabilities, the platform ensures efficiency from early development through GMP manufacturing and beyond.
Addressing Unmet Needs in Immune Disorders
Quell Therapeutics is pioneering engineered T-regulatory cell therapies to create transformative treatments for immune and inflammatory disorders. The company's approach leverages the unique properties of Tregs to restore balance in the immune system, potentially offering new options for patients with limited treatment alternatives.
"AGC Biologics provides the reliability, speed and efficiency we need as we prepare our Treg therapies for clinical trials," said Aaron Vernon, Chief Manufacturing Officer at Quell Therapeutics. "This partnership is critical as we work to address severe immune disorders and bring innovative treatments to patients. We are looking forward to working with the AGC Biologics team of experts to support our programs into clinical development."
Manufacturing Excellence and Global Capabilities
The AGC Biologics Milan Cell and Gene Center of Excellence brings significant expertise to the partnership, with 30 years of experience in cell and gene therapy, nine commercial approvals, and hundreds of successfully produced GMP batches. The site 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.
The center's teams have established a reputation for collaboration, working closely with customers to achieve clinical, late-phase, and commercial successes. This partnership is part of AGC Biologics' broader strategy within its Cell and Gene Technologies Division, which operates a global network of facilities designed to help partners accelerate drug development timelines while maintaining the highest quality standards.
Cost-Effective Approach to Advanced Therapies
AGC Biologics has emphasized its commitment to making life-saving treatments more cost-effective. The company aims to offer lentiviral vectors for commercial applications at costs as low as $1,000 per patient, potentially addressing one of the significant barriers to widespread adoption of advanced cell and gene therapies.
This partnership represents a significant step forward in the development of novel Treg cell therapies and highlights the growing importance of specialized manufacturing capabilities in advancing the next generation of treatments for immune disorders.
