AGC Biologics, your friendly CDMO expert, announced a partnership with Quell Therapeutics, a clinical-stage biotechnology company pioneering engineered T-regulatory (Treg) cell therapies. This collaboration supports the development of multiple Treg cell therapy drug candidates targeting severe immune disorders. AGC Biologics will provide lentiviral vector (LVV) material using its proprietary ProntoLVV™ platform to prepare these therapies for CTA / IND submissions.
Quell is working to create transformative treatments for immune and inflammatory disorders by using the unique properties of Tregs to restore balance in the immune system. Under this agreement, AGC Biologics’ Milan Cell and Gene Center of Excellence is producing LVV material for Quell Treg cell therapy candidates. With the ProntoLVV platform process, AGC Biologics will integrate Quell’s gene of interest into its standardized production protocols with off-the-shelf starting materials, offering flexibility for both suspension and adhesion systems. This approach helps ensure GMP readiness and a smoother transition to GMP manufacturing and 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, 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.”
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“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, 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.”
The AGC Biologics Milan Cell and Gene Center of Excellence offers 30 years of experience in cell and gene therapy, with nine commercial approvals and hundreds of GMP batches produced successfully. The site holds commercial manufacturing authorizations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for viral vectors and cell therapies. The teams of experts there have a reputation for collaboration and working side-by-side with customers to find clinical, late-phase and commercial successes. AGC Biologics’ Cell and Gene Technologies Division has a global network of facilities to help partners accelerate their drug development timelines while supporting the highest quality standards in the industry. Under this division’s leadership, AGC Biologics is focused on making life-saving treatments more cost-effective and aims to be able to offer lentiviral vectors for commercial applications at a cost as low as 1,000 USD per patient.
With AGC Biologics’ ProntoLVV platform, lentiviral vector production is now more streamlined. Standardized procedures reduce the amount of time needed while maintaining flexibility and include high-quality, ready-to-use packaging plasmids, a unique gene transfer system, and the necessary documentation to support regulatory submissions. ProntoLVV includes in-house analytics, and production is scalable, ensuring efficiency from early development all the way through GMP manufacturing and beyond.
Source: Businesswire