Latest news with #AGCBiologics
Yahoo
31-07-2025
- Automotive
- Yahoo
European Commission Approves CAR-T Therapy With Lentiviral Vectors Manufactured by AGC Biologics
The Friendly CDMO Expert's Milan Cell and Gene Center of Excellence Achieves 10th Major Regulatory Product Approval MILAN, July 31, 2025--(BUSINESS WIRE)--Following news on July 21 that the European Commission has granted marketing authorization for AUCATZYL® (obecabtagene autoleucel – obe-cel), AGC Biologics' Milan site achieved its 10th product approval from the European Medicines Agency or the U.S. Food and Drug Administration. Developed by Autolus Therapeutics, AUCATZYL® is now approved to treat adult patients (age 26 and older) in 27 European Union member states with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This follows the therapy's prior authorizations from the FDA in November 2024 and the U.K. Medicines and Healthcare products Regulatory Agency in April 2025. This latest step further solidifies AGC Biologics' Milan Cell and Gene Center of Excellence's reputation as a global leader in the field, built on a 30-year track record of quality, reliability, and regulatory success. "This European approval for Autolus is a milestone we are thrilled to be part of. Our goal is to be the industry's safe harbor: a trusted, friendly expert CDMO that de-risks the complex path to commercialization," said Alberto Santagostino, CEO and President, AGC Biologics. "By ensuring a reliable supply of their vital lentiviral vector, we empower our partners to focus on patients. Congratulations to the entire Autolus team." The partnership between Autolus and AGC Biologics Milan began in 2020, with the CDMO tasked to develop, manufacture, and supply the viral vectors for Autolus' obe-cel CAR-T product candidate. "From the start of our partnership in 2020, through the FDA approval and now this European authorization, our collaboration with Autolus has been a model of true partnership," said Luca Alberici, General Manager, AGC Biologics Milan. "The team's sustained dedication and technical excellence is a direct result of our ability to work seamlessly with the Autolus team to meet the demands of commercial-scale manufacturing for a global market." With its 30-year track record and 10 product approvals by the EMA and FDA, the AGC Biologics Milan site is a global leader with deep expertise in complex cell and gene therapy projects. The team has guided numerous products to commercial stages, manufactured hundreds of batches for clinical supply, and consistently met the highest global regulatory guidelines, quality performance metrics, and the unique complexities of technology transfers and manufacturing scale-up. To learn more about AGC Biologics' global cell therapy services, visit and for more on the CDMO's viral vector offerings, 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 2,600 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 AUCATZYL® (obecabtagene autoleucel – obe-cel) is a registered trademark of Autolus Therapeutics. View source version on Contacts AGC Inc. corporate contact: info-pr@ AGC Biologics media contact: ksills@ Sign in to access your portfolio
Business Wire
29-07-2025
- Business
- Business Wire
AGC Biologics' Heidelberg Site Supplies Drug Substance for Phase II Studies of Valneva's Tetravalent Shigella Vaccine Candidate
SEATTLE & HEIDELBERG, Germany--(BUSINESS WIRE)-- AGC Biologics, your friendly CDMO expert, today announced a development and manufacturing services agreement with specialty vaccine company Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) to supply drug substance for an investigational four-valent Shigella bioconjugate vaccine at the CDMO's Heidelberg facility. Valneva exclusively licensed the vaccine candidate from LimmaTech Biologics AG, which previously worked with AGC Biologics to establish GMP-compliant manufacturing and quality control of the vaccine's complex protein-polysaccharide conjugates for first-in-human studies. The objective of the new partnership with Valneva is to establish phase II supply relying on the ability of AGC Biologics' Heidelberg site to guide complex molecules through clinical stages. Valneva and LimmaTech announced the launch of a Phase 2 infant study in April, and a Phase 2b Human Challenge Study (CHIM) in November 2024. Shigellosis is the second leading cause of fatal diarrheal disease worldwide, strongly contributing to pediatric morbidity and mortality. It is estimated that up to 165 million infections are due to Shigella, of which 62.3 million occur in children younger than five years. Developing an effective vaccine to prevent this deadly disease is a public health imperative for many areas of the world. "Our site's unique ability to handle complex molecules and multi-valent assets can help this potentially life-saving program reach its next clinical milestone," said Dieter Kramer, Senior Vice President and General Manager, AGC Biologics Heidelberg. "We appreciate Valneva entrusting our team of experts with this challenge and are honored to contribute to efforts that aim to prevent millions of deadly infections in the future." AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The site has produced biologics products for 40 years. It offers developers freedom-to-operate strain development, proven experience with different bacterial and yeast systems, proprietary plasmid DNA (pDNA) and messenger RNA (mRNA) platforms, large-scale tanks for late-phase protein refolding, the ability to take on early-phase and fast track projects, and late-phase and commercial expertise. To learn more about the microbial system-based biologics, pDNA and mRNA manufacturing site in Heidelberg, visit For more information on AGC Biologics' global CDMO services across all modalities, go to 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. 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
17-07-2025
- Business
- Yahoo
From Seattle to Chiba: Okayama University Taps AGC Biologics' Global Pathway for New Therapeutic
SEATTLE & CHIBA, Japan, July 17, 2025--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced a new service agreement with Okayama University, a prominent national university in Japan. This project will leverage AGC Biologics' global network, with the mammalian cell line development capabilities in Seattle, USA, and cGMP mammalian manufacturing facility in Chiba, Japan, working together to advance a new therapeutic program for the university. Under the agreement, AGC Biologics will perform cell line development with its proprietary CHEF1™ expression platform in Seattle. CHEF1's track record includes the production of more than 55 different molecules and the development of five commercial products brought to market. The program will then be transferred to the company's facility in Chiba for process development for clinical trials in 2026. The collaboration between its Asian and U.S. sites highlights AGC Biologics' ability to offer research institutions a seamless, global pathway from early-stage development to clinical manufacturing. "This project is a perfect example of our winning global blend, combining the world-class cell line development excellence in Seattle with the most-advanced cGMP-compliant mammalian cell culture manufacturing capabilities available in Japan," said Susumu Zen-in, General Manager of AGC Biologics' Chiba facility. "By providing a high level of global standard expertise and an emphasis on flexibility, we're able to effectively serve prestigious academic institutions like Okayama University working to bring vital new medicines to patients." Okayama University selected AGC Biologics for its integrated global network and its unique position in Japan. The Chiba facility offers mammalian cell culture-based services to serve the needs of customers from Japan and the surrounding regions. This partnership underscores AGC Biologics' commitment to supporting academic and research institutions by providing the technical creativity and specialized services needed to solve complex challenges and advance important new therapies. To learn more about AGC Biologics' global network of 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 2,600 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 AGC Inc. Corporate contact: info-pr@ AGC Biologics press contact: ksills@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Wire
17-07-2025
- Business
- Business Wire
From Seattle to Chiba: Okayama University Taps AGC Biologics' Global Pathway for New Therapeutic
SEATTLE & CHIBA, Japan--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced a new service agreement with Okayama University, a prominent national university in Japan. This project will leverage AGC Biologics' global network, with the mammalian cell line development capabilities in Seattle, USA, and cGMP mammalian manufacturing facility in Chiba, Japan, working together to advance a new therapeutic program for the university. Under the agreement, AGC Biologics will perform cell line development with its proprietary CHEF1™ expression platform in Seattle. CHEF1's track record includes the production of more than 55 different molecules and the development of five commercial products brought to market. The program will then be transferred to the company's facility in Chiba for process development for clinical trials in 2026. The collaboration between its Asian and U.S. sites highlights AGC Biologics' ability to offer research institutions a seamless, global pathway from early-stage development to clinical manufacturing. 'This project is a perfect example of our winning global blend, combining the world-class cell line development excellence in Seattle with the most-advanced cGMP-compliant mammalian cell culture manufacturing capabilities available in Japan,' said Susumu Zen-in, General Manager of AGC Biologics' Chiba facility. 'By providing a high level of global standard expertise and an emphasis on flexibility, we're able to effectively serve prestigious academic institutions like Okayama University working to bring vital new medicines to patients.' Okayama University selected AGC Biologics for its integrated global network and its unique position in Japan. The Chiba facility offers mammalian cell culture-based services to serve the needs of customers from Japan and the surrounding regions. This partnership underscores AGC Biologics' commitment to supporting academic and research institutions by providing the technical creativity and specialized services needed to solve complex challenges and advance important new therapies. To learn more about AGC Biologics' global network of 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 2,600 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
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.
