Latest news with #ProntoLVV
Business Wire
26-06-2025
- Business
- Business Wire
AGC Biologics Expands Cell Therapy Development Operations to Asia to Serve Growing Market Need
TOKYO--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, will commence cell therapy process development and clinical manufacturing services on July 1, 2025, at AGC Inc.'s Yokohama Technical Center, marking the latest step in the global expansion of the company's Global Cell and Gene Technologies Division. The improved geographical footprint allows AGC Biologics to better serve customers requiring autologous and allogeneic products across all markets, with cell therapy manufacturing now available in three continents (Milan, Italy – Longmont, Colorado, U.S. – Yokohama, Japan). This new site precedes the opening of a new AGC Biologics Yokohama manufacturing facility on schedule to be operational in 2027 with pre-clinical through commercial services for mammalian-based protein biologics, cell therapies, and messenger RNA. The Yokohama location will provide process transfer and manufacturing services for pre-clinical and clinical trials to serve an expanding global cell therapy market. Its core technologies include induced pluripotent stem cells, mesenchymal stem cells, hematopoietic stem cells, and CAR-T cell therapies. AGC Biologics Cell and Gene Technology Center of Excellence in Milan, with its nine product approvals by the EMA and FDA, hundreds of batches manufactured, and 30-year track record, will support and enable the successful ramp up of operation in the new Yokohama site. 'In a cell and gene therapy market of high volatility and witnessing consolidation of CDMOs, AGC Biologics is among the few experiencing significant growth and success. We are now building on this success to complete the vision of having a truly global offering,' said Luca Alberici, Executive Vice President of Global Cell and Gene Technologies at AGC Biologics. 'Now Asian developers can benefit from having a local supply within one of the best global infrastructures on the market for cell therapy. Moreover, customers can continue to leverage the offering of viral vector central supply in our Milan facility, which supplies around a third of the ex vivo gene therapy product approved for commercialization. AGC Biologics, through its proprietary ProntoLVV and BravoAAV platforms, aims to offer viral vectors at a sustainable cost for its clients targeting less than 1,000€ per CAR-T patient.' 'Our team of friendly experts in Milan have a strong reputation for collaboration and working side-by-side with customers to achieve clinical, late-phase, and commercial successes,' said Jun Takami, Senior Vice President and General Manager, Japan Region and Yokohama Facility. 'As part of this next major phase for cell therapy in the region, our Yokohama team is ready to support partners in accelerating drug development timelines while maintaining the highest quality standards in the industry." AGC Biologics is a part of AGC Inc.'s Life Science Company. The Life Science company operates over 10 facilities worldwide focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. The AGC Inc. Yokohama Technical Center, built in 2020, is dedicated to advancing AGC Inc.'s research and development capabilities in materials science, chemical processes, and biotechnology. Please visit to learn more about AGC Biologics' global network of services for protein biologics and cell and gene therapies. 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 2,600 Team Members worldwide.
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@
