Latest news with #LucaAlberici
Yahoo
15-05-2025
- Business
- Yahoo
AGC Biologics Partners with Quell Therapeutics to Advance T-Regulatory Cell Therapies for Immune Disorders
SEATTLE & MILAN, May 15, 2025--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced a partnership with Quell Therapeutics ("Quell"), 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." "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. AGC Biologics offers a comprehensive suite of services for viral vector-based therapies, from process development to commercial manufacturing. About Quell Therapeutics: Quell Therapeutics is a world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system. The Company is leveraging its proprietary Foxp3 Phenotype Lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches. Quell's lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in other autoimmune and inflammatory diseases. To learn more please visit About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit View source version on Contacts Media ContactNick McDonaldAGC Biologicsnmcdonald@ AGC Inc. Media Contactinfo-pr@ Luke Henry, Chief Business OfficerQuell TherapeuticsIR@ Media: Mark Swallow, Sandi Greenwood, Erica HollingsworthMEDiSTRAVA Quell-Tx@ Investors: Corey DavisLifeSci Advisorscdavis@
Business Wire
15-05-2025
- Business
- Business Wire
AGC Biologics Partners with Quell Therapeutics to Advance T-Regulatory Cell Therapies for Immune Disorders
SEATTLE & MILAN--(BUSINESS WIRE)-- AGC Biologics, your friendly CDMO expert, today announced a partnership with Quell Therapeutics ('Quell'), 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.' '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. AGC Biologics offers a comprehensive suite of services for viral vector-based therapies, from process development to commercial manufacturing. About Quell Therapeutics: Quell Therapeutics is a world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system. The Company is leveraging its proprietary Foxp3 Phenotype Lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches. Quell's lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in other autoimmune and inflammatory diseases. To learn more please visit About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit
Yahoo
15-05-2025
- Business
- Yahoo
AGC Biologics Partners with Quell Therapeutics to Advance T-Regulatory Cell Therapies for Immune Disorders
SEATTLE & MILAN, May 15, 2025--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced a partnership with Quell Therapeutics ("Quell"), 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." "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. AGC Biologics offers a comprehensive suite of services for viral vector-based therapies, from process development to commercial manufacturing. About Quell Therapeutics: Quell Therapeutics is a world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system. The Company is leveraging its proprietary Foxp3 Phenotype Lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches. Quell's lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in other autoimmune and inflammatory diseases. To learn more please visit About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit View source version on Contacts Media ContactNick McDonaldAGC Biologicsnmcdonald@ AGC Inc. Media Contactinfo-pr@ Luke Henry, Chief Business OfficerQuell TherapeuticsIR@ Media: Mark Swallow, Sandi Greenwood, Erica HollingsworthMEDiSTRAVA Quell-Tx@ Investors: Corey DavisLifeSci Advisorscdavis@
Yahoo
02-04-2025
- Business
- Yahoo
AGC Biologics Forms Dedicated "Cell and Gene Technologies Division," Designed to Build Upon Their Track Record of Nine Commercially Approved Products to Date
Luca Alberici appointed to lead new Division offering focused technical innovation, product platform design, scalable manufacturing, and friendly customer experience for the underserved Advanced Therapy market MILAN & SEATTLE, April 02, 2025--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced the formation of a new Cell and Gene Technologies Division designed to focus and elevate existing AGC Biologics capabilities and further foster the company's performance as the most reliable, experienced and friendly advanced therapy CDMO worldwide. AGC Biologics is investing and growing in a market with substantial capacity but limited scientific capabilities and technically qualified operators. While other cell and gene CDMOs are closing sites and downsizing their workforce, the new AGC Biologics Cell and Gene Technologies Division offers unparalleled support and scientific ability, backed by an abundant global development and manufacturing network in three regions (Milan, Italy; Longmont, CO, USA; Yokohama, Japan). Further, AGC Biologics' proprietary cell therapy and viral vector platforms, including ProntoLVV™ and BravoAAV™, offer developers the ability to increase their speed to GMP phases while controlling costs significantly. The AGC Biologics Milan Cell and Gene Center of Excellence will be the central location for this new Division. The site offers 30 years of experience in cell and gene therapy, with nine commercial approvals and hundreds of GMP batches produced successfully, and its teams of experts have a reputation for collaboration and working side-by-side with customers to find clinical, late-phase, and commercial successes. Recognized as one of the most accomplished cell and gene CDMO production sites in the world, it 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 Cell and Gene Center of Excellence has also shown considerable momentum over the last 12 months, achieving two FDA commercial approvals (Lenmeldy™ and Aucatzyl®) and organic business growth of over 20 percent in a declining market. This year also started very fruitful for the site, with new agreements for commercial lentiviral vector services, adeno-associated viral vector services, autologous and allogenic cell therapy agreements, and an exosome project, reinforcing its leading position in this space. The 140,000-square-foot facility (13,000 m2) offers complete end-to-end services, including research and development (R&D) and innovation teams supporting initial development and early clinical phases, expanded large-scale viral vector suites with scales up to 2,000 L, new cell therapy suites, and a dedicated floor for quality control, which performs all necessary tests in-house. These unique features help the site deliver a safe path from IND to commercialization for customers. The Milan facility has guided five viral vectors and four cell therapy products from early clinical phases through commercialization, demonstrating a strong acumen for important late-stage and commercial manufacturing partnerships. The new Cell and Gene Technologies Division features expanded global capabilities, including AGC Biologics' Longmont facility and the new Yokohama facility, which will begin cell therapy operations in July 2025. The new Division aims to "Bring Hope to Life Together" with developers in the global cell and gene industry and inspire progress for these promising treatments. The Cell and Gene Technologies Division offers support for R&D initiatives, solves complexities in clinical stages, builds scalable manufacturing processes, and addresses the unique needs of developers based on the geographical regions they operate in. Luca Alberici has been appointed Executive Vice President of the Cell and Gene Technologies Division. He will report directly to Alberto Santagostino, President and CEO, and join the company's executive leadership team. Alberici will oversee this new Division's global strategy, operations, and commercial development, and he will keep his current 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." "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 Luca 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," noted Alberici. To learn more about AGC Biologics and its global CDMO services, visit About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit View source version on Contacts Media Contact Nick McDonaldAGC Biologicsnmcdonald@ AGC Inc. Media Contact info-pr@ Sign in to access your portfolio
