Latest news with #AGCBiologics
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@
Business Wire
06-05-2025
- Business
- Business Wire
AGC Biologics Partners with Novelty Nobility for Cell Line Development and Phase I Preparations of Antibody Drug Candidate
COPENHAGEN, Denmark & CHIBA, Japan--(BUSINESS WIRE)-- AGC Biologics, your friendly CDMO expert, today announced a multiphase partnership with Novelty Nobility Inc., a clinical-stage biotech company based in South Korea. Novelty Nobility will leverage AGC Biologics' expertise and proprietary CHEF1® expression technology for cell line development and prepare for Phase I clinical trials via a multi-site partnership with AGC Biologics' Copenhagen, Denmark and Chiba, Japan facilities. When clients work with us, they tap into our entire global network – we find the right expertise wherever it exists and bring teams together for a seamless experience, no matter where the work is being done. Share Novelty Nobility develops innovative antibody drugs, including bispecific antibodies and antibody-drug conjugates (ADCs). The company is currently developing two clinical assets in the United States in immunology and oncology, respectively. AGC Biologics will develop the cell line and create a master cell bank (MCB) for Novelty Nobility's first-in-class bispecific antibody drug candidate at its Copenhagen facility. After the MCB is created, the second phase of the partnership will focus on expanded process development work and GMP manufacturing preparation at the AGC Biologics Chiba site. The first stage of the project began in March. "We are very happy with the partnership with Novelty Nobility, where we will apply our CHEF1 platform to a novel bispecific antibody, helping support the advancement of this important candidate towards clinical trials," said Kasper Møller, Chief Technical Officer and Executive Vice President, AGC Biologics. "Our cell line development expertise in Copenhagen is strategically aligned with Novelty Nobility's objectives, and we believe we can provide a strong foundation for their therapeutic development program." "Chiba's partnership with our Copenhagen team gives Novelty Nobility access to world-class cell line development experts while keeping their regional connection strong," noted Susumu Zen-in, Senior Vice President and General Manager, AGC Biologics Chiba. "When clients work with us, they tap into our entire global network – we find the right expertise wherever it exists and bring teams together for a seamless experience, no matter where the work is being done. This approach is already helping us throughout the APAC region and creating wins for both Novelty Nobility and AGC Biologics." AGC Biologics' CHEF1 expression technology is a proven platform for cell line development, with a track record of producing stable cell lines for a variety of biologics. With five commercial products on the market and 54 distinct molecules developed, the platform delivers a reliable and efficient path to success. The cell line platform excels in handling complex molecules, providing solutions for challenging biologics that require specialized expression systems. The CHEF1 platform is also royalty-free, eliminating additional costs for clients as their products advance through clinical phases toward commercialization. AGC Biologics offers a comprehensive suite of services for mammalian-based drug production, from cell line development to commercial manufacturing, enabling partners to accelerate their drug development timelines and bring life-changing therapies to patients. Visit to learn more. About Novelty Nobility Inc. Novelty Nobility is a clinical stage biotechnology company developing fit-for-purpose antibodies to deliver meaningful therapeutic benefits to patients. Starting with the end in mind, the Company is crafting tailored solutions by matching the right antibody modality to the underlying mechanisms of a specific disease. While this 'good' antibody approach can be used in many treatments, this versatility isn't automatic—it is supported by our design-driven antibody discovery platform, PREXISE®-D, to ensure the best results for each application. 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
Yahoo
07-04-2025
- Business
- Yahoo
AGC Biologics Strengthens Single-Use Technology Network and Adds 5,000 L Vessels from Thermo Scientific to New Yokohama, Japan Facility
CDMO's new site introducing the most advanced and large-scale single-use bioreactors in the region YOKOHAMA, Japan & SEATTLE, April 07, 2025--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced a strategic decision about the large-scale single-use technology it will use at its new Yokohama, Japan facility. The CDMO is introducing two 5,000 L Thermo Scientific DynaDrive Single-Use Bioreactors (S.U.B.), which makes the site one of the most advanced in Japan for large-scale mammalian-based biologics production, with GMP operations beginning in 2027. According to 2024 data from BDO Group's bioTRAK Database, single-use technology represents 51 percent of all mammalian bioreactor technology globally, outpacing the traditional stainless-steel alternative. Attributes driving this trend include fewer cleaning requirements, lower cost barrier to entry and timeline for setup, flexible configurations, scalability to meet changing product demands, and shorter clinical production timelines. AGC Biologics has the second largest global network of single-use manufacturing capacity by volume in the industry, according to bioTRAK. The new bioreactor technology ensures the company stays ahead of industry-wide demand for single-use systems. "The new Yokohama site is designed to utilize single-use bioreactors to offer large-scale GMP manufacturing. The cutting-edge technology from Thermo Scientific makes this one of the most advanced sites in Japan for large-scale manufacturing and further expands our robust global network of single-use manufacturing sites on three continents," said Christoph Winterhalter, Chief Business Officer, AGC Biologics. "This location offers the capabilities to meet the commercial needs of customers in Japan and Asia, as well as global customers seeking capacity using the latest technology." "Flexibility and the means to scale production cost-effectively is key for any developer of therapies today, and CDMOs need the best technology possible to help them accomplish that. The DynaDrive 5,000 L Single-Use Bioreactor delivers seamless scalability, exceptional flexibility, and superior process intensification capabilities – embodying best-in-class performance. AGC Biologics' new site in Yokohama will be a premier site in Japan for large-scale single-use technology thanks to our collaboration," said Daniella Cramp, Senior Vice President and President of Thermo Fisher Scientific's Bioproduction business. The new AGC Biologics Yokohama facility will offer support from initial process development work for early-phase projects to late-phase and commercial production. It will support mammalian expression, cell therapy, and messenger RNA (mRNA) drug products. The Yokohama facility is expected to help maximize operational and supply chain efficiencies across AGC Biologics' global network by adding another site in the region. The CDMO currently operates one site in Japan, its Chiba facility, offering mammalian expression and microbial fermentation services. 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. To learn more about AGC Biologics' global network of services for protein biologics and cell and gene therapies, 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 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
