AGC Biologics has partnered with Quell Therapeutics to advance the development of engineered T-regulatory (Treg) cell therapies targeting severe immune disorders.
Under the partnership, AGC Biologics will supply lentiviral vector (LVV) material through its ProntoLVV platform to develop multiple Treg cell therapy drug candidates.
Quell will leverage its expertise in advanced treatments for immune and inflammatory disorders by using unique properties of Tregs to restore immune system balance.
AGC Biologics’ Milan Cell and Gene Centre of Excellence will produce LVV material for Quell’s Treg cell therapy candidates.
It will integrate Quell’s gene of interest into its ProntoLVV platform’s standardised production protocols, offering flexibility for both suspension and adhesion systems.
The approach ensures GMP readiness and facilitates a smoother transition to GMP manufacturing and clinical trials.
AGC Biologics global cell and gene technologies executive vice president Luca Alberici said: “Our ProntoLVV platform is well-suited to support Quell in advancing its Treg cell therapies toward clinical trials.
“By combining standardised 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 Milan Cell and Gene Centre of Excellence has 30 years of experience in cell and gene therapy, with nine commercial approvals and hundreds of GMP batches produced.
The site holds manufacturing authorisations from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for viral vectors and cell therapies.
AGC Biologics’ Cell and Gene Technologies Division has a global network of facilities to expedite drug development timelines while maintaining high-quality standards.
The division aims to make life-saving treatments more cost-effective, to provide lentiviral vectors for commercial applications at a cost as low as $1,000 per patient.
The ProntoLVV platform streamlines lentiviral vector production with standardised procedures, reducing time while maintaining flexibility.
It includes high-quality, ready-to-use packaging plasmids, a unique gene transfer system, and necessary documentation for regulatory submissions.
The platform’s in-house analytics and scalable production ensure efficiency from early development through GMP manufacturing.
Quell Therapeutics chief manufacturing officer Aaron Vernon said: “AGC Biologics provides the reliability, speed and efficiency we need as we prepare our Treg therapies for clinical trials.
“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.”
