WA-AGC-BIOLOGICS
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new commercial manufacturing project at its Seattle protein biologics manufacturing site. The CDMO is producing TZIELD™ (teplizumab-mzwv), a new T1D treatment from Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases.
Provention Bio chose AGC Biologics to manufacture TZIELD after the CDMO helped guide the product through PPQ manufacturing and validation batches, and United States Food and Drug Administration (FDA) approval. More than 1.8 million Americans have T1D, an autoimmune disease caused by the destruction of beta cells. TZIELD is the first and only immunomodulatory treatment that delays the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older. Patients who progress to Stage 3 T1D will eventually require insulin injections for life.
“The multi-year process of shepherding a new therapy from clinical research to commercial launch requires the collaboration of multiple partners, and we are grateful for the ongoing strategic collaboration of AGC Biologics as we begin to deliver TZIELD to patients,” said Provention Bio CEO Ashleigh Palmer. “This is an important milestone for the Type 1 Diabetes community, and we hope the launch of this therapy can truly make an impact on patients and families seeking innovative treatments for the delay of Stage 3 T1D.”
AGC Biologics runs multiple mammalian cGMP manufacturing lines and a variety of scales at its Seattle facility. The campus serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes and houses a new microbial-based manufacturing line system. The AGC Biologics Seattle campus has produced biologics products for 30 years and has a long history of successful inspections by the FDA and commercial production.
“Congratulations to Provention Bio on this game-changing achievement for T1D patients,” said Kevin Ingham, General Manager of AGC Biologics’ Seattle site. “We at AGC Biologics are proud to have helped develop this innovative new medicine and to be manufacturing it for commercial distribution. This achievement demonstrates our Seattle site’s increasing track record in commercial manufacturing, which is aligned with AGC Biologic’s purpose of bringing hope to life.”
To learn more about AGC Biologics’ mammalian and microbial system-based biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle. For more information on the company’s Protein Biologics, Protein DNA (pDNA), Cell Therapy, Viral Vector and Messenger RNA (mRNA) drug product services visit www.agcbio.com.
About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including T1D, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.
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, every step of the way. We provide world-class development and manufacture 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 and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,000 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230124005438/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ahead of Holiday Season, Visa Identifies Five Transformative Forces Reshaping Global Payment Security20.11.2025 19:50:00 CET | Press release
New Biannual Threats Report Reveals Fundamental Shift in Fraud Operations as Criminals Adopt Industrial-Scale Tactics To celebrate International Fraud Awareness Week, Visa (NYSE: V) today released its Fall 2025 Biannual Threats Report, revealing five forces that are transforming the global payments security landscape. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120412198/en/ The report, produced by Visa's Payment Ecosystem Risk and Control (PERC) team, draws on intelligence from Visa's global network to identify how criminal operations are evolving with unprecedented speed, scale, and sophistication. "The payments ecosystem is experiencing a paradigm shift in how fraud operates," said Paul Fabara, Chief Risk and Client Services Officer at Visa. "Criminals are no longer working as opportunistic individuals-- they're operating like tech startups, building reusable infrastructure and deploying systematic, industrial-scale
Suzano Forms Partnership with Tencent and Ecofuturo Institute at COP30 for AI-Powered Conservation and Nature Education20.11.2025 18:25:00 CET | Press release
New agreement signed at COP30 will see organisations collaborating to use artificial intelligence tools for biodiversity monitoring and digital platforms to boost public engagement in conservation efforts. The world’s largest pulp supplier, Suzano, today announces the signing of a Memorandum of Understanding (MoU) with the multinational technology business Tencent and the Brazilian non-profit Ecofuturo Institute, to pioneer new digital approaches to drive public engagement in conservation. The collaboration will leverage Suzano’s expertise in sustainable forestry, Tencent’s cutting-edge digital technology, and Ecofuturo’s expertise in environmental education, to pilot joint initiatives in both Brazil and China. These include enhancing ecological awareness, accelerating biodiversity solutions, and leveraging digital platforms to foster public engagement in conservation. The partnership will result in a pilot project where advanced AI tools for species recognition developed by Tencent’s
EMVCo Working on How Global Specifications Can Support Agentic Payments20.11.2025 17:38:00 CET | Press release
EMVCo – the technical body that creates and manages EMV® Specifications and programmes that enable seamless and secure card-based payments worldwide – has announced that it is working on how global specifications can support innovation in agentic payment solutions by increasing trust and interoperability across the ecosystem. Agentic commerce is rapidly reshaping the shopping experience by enabling AI agents to act on the consumer’s behalf. This is driving significant momentum for agentic payments, which introduce AI agents as new actors that can initiate transactions with merchants – without requiring direct involvement from the consumer. While agentic payments have the potential to increase convenience and personalisation, they present unique considerations for how transactions are initiated, authenticated and secured. As industry adoption and innovation accelerate, a globally interoperable and scalable approach may be beneficial in realising trusted agentic payments for consumers, m
Université Paris-Saclay and Owkin: A Unique Alliance to Propel University Medical Research to the Top of the European Rankings Through AI20.11.2025 15:17:00 CET | Press release
Université Paris-Saclay and Owkin announce the signing of a memorandum of understanding to explore the potential of K Pro Free - Owkin’s AI co-pilot for biology - for use by Paris-Saclay. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120130113/en/ K Pro Free will now be available to the entire Université Paris-Saclay community, and in particular teachers, researchers and doctoral students working in the biomedical sciences. The partnership includes workshops, training sessions and events designed to promote the discovery and adoption of K Pro Free, as well as the co-organization of communication and dissemination initiatives around the use of AI in health. In this way, the partnership will promote user training, but also enrich and continuously improve the co-pilot's models through feedback and use cases from the l’Université Paris-Saclay community. This partnership is part of Université Paris-Saclay’s strategy to integr
Frasca Advances Flight Training Technology with New Visual System Powered by Unreal Engine20.11.2025 15:05:00 CET | Press release
Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced the launch of VITAL FVS 100, the next evolution of its visual system technology. Building on the proven TruVision Global platform, VITAL FVS 100 was developed using Epic Games’ Unreal Engine and delivers unprecedented realism, scalability, and innovation in pilot training. The Unreal-powered VITAL FVS 100 system introduces major advancements in visual fidelity and training realism, further enhancing the capabilities of Frasca, a leading developer of flight simulators and training devices. The new system includes physically based renderings, advanced lighting effects, and a new volumetric cloud model that creates dynamic, weather-rich environments. Terrain imagery now includes one-meter resolution coverage for the contiguous United States and Hawaii, with expanded global datasets covering European buildings and tree covered regions. Additionally, enhanced particle effects re
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom