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
Hanseo University Expands Aviation Training Program with New Frasca Flight Training Device10.12.2025 16:05:00 CET | Press release
The new device marks the latest milestone in a long-standing collaboration between Hanseo University and Frasca International, Inc. Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced that Hanseo University in South Korea is expanding its aviation program with a new Level 5 Cessna 172 Flight Training Device (FTD), the seventh Frasca device to join the university’s fleet. Hanseo University’s school of Aeronautical Science recognized by the Korean University Accreditation Institute as the nation’s first Specialized University for Training Professional Workforce Industries, continues to expand its state-of-the-art simulation capabilities with the acquisition of a Level 5 Cessna 172 FTD. The addition builds on a partnership with Frasca that has spanned more than two decades and further advances aviation education across Asia. “We were seeking simulators that provided both realism and reliability, and Frasca stood out immediately
Bregal Milestone Announces Majority Growth Investment in Beyond Now10.12.2025 16:00:00 CET | Press release
Partnership to Drive Beyond Now’s AI-Led Innovation and Expansion Bregal Milestone, a leading European software growth private equity firm, today announced a majority growth investment in Beyond Now (the “Company”), a fast-growing, cloud-native supply chain software provider for AI-enabled digital commerce. Driven by strong customer demand, Beyond Now has generated profitable growth and >40% last twelve-month ARR growth. Beyond Now supports some of the world’s largest and most innovative Communication Service Providers (CSPs), including Verizon, AT&T, Deutsche Telekom, and NTT, in managing complex digital supply chains to create seamless end-to-end partner and customer operations. Founded in 2018, the Company serves telecommunication providers, technology companies, and private enterprises to efficiently scale and monetize digital services through its suite of modern, Ecosystem Orchestration and Digital Platforms - including an AI Digital Business Platform for orchestrating partner off
NetJets to Bring Starlink High-Speed Connectivity to Fleet10.12.2025 15:05:00 CET | Press release
The agreement between the two companies will bring reliable Wi-Fi connectivity to one of the world’s largest fleets of jets, ensuring a seamless, best-in-class experience for Owners NetJets, the global leader in private aviation, and Starlink have entered into an agreement to bring high-speed in-flight connectivity to 600 aircraft across NetJets’ global fleet by the end of 2026, unlocking a new level of productivity and exceptional travel experiences in the air. “This agreement with Starlink positions NetJets to continue delivering exceptional travel experiences for our Owners and their guests,” said Patrick Gallagher, President, NetJets Aviation. “With Starlink, travel is elevated with reliable connectivity whether our Owners are flying for business or leisure—as seamless connectivity is critical to the experience our Owners need and deserve.” This multi-year, service level agreement paves the way for NetJets to quickly and seamlessly outfit its aircraft across the U.S. and Europe, wi
Mercator Ocean International Makes AI Ocean Forecasting Operational with GLONET Validated by OceanBench at NeurIPS 202510.12.2025 15:00:00 CET | Press release
New benchmark sets the first science-based quality standard for AI ocean models, enabling GLONET’s operational deployment At NeurIPS 2025, one of the world’s leading AI conferences, Mercator Ocean unveiled OceanBench, the first open benchmark designed to assess AI Ocean forecasting models. This milestone follows the publication of Mercator Ocean’s AI model GLONET in September. Together, OceanBench and GLONET represent a decisive step toward integrating artificial intelligence into operational ocean forecasting, strengthening Europe’s leadership in trustworthy, AI-driven predictions at global scale. Presented by Anass El Aouni, Oceanographer and machine learning (ML) researcher, and Quentin Gaudel, ML Systems Architect, OceanBench establishes a unified standard to evaluate AI models against fundamental ocean dynamics. GLONET is the first forecasting system to be validated through OceanBench for operational use. Anass El Aouni : “OceanBench provides a transparent standard to evaluate AI-
Cleveland Clinic Neurological Institute and Baszucki Group Team Up to Advance Landmark Brain Study with Metabolic Health Markers10.12.2025 15:00:00 CET | Press release
The collaboration seeks to study gut-brain connections in neurological disorders Baszucki Group today announced an expanded commitment to the landmark Cleveland Clinic Brain Study. Launched in 2022, this ambitious longitudinal study plans to follow healthy individuals over a 20-year period with the goal of identifying early disease markers and therapeutic targets needed to prevent and ultimately cure neurological diseases. The commitment from Baszucki Group brings their total donation to the study to $450,000. The commitment was announced at Keep Memory Alive’s annual Summer Festival & Rodeo at Shakespeare Ranch in Glenbrook, Nevada, an event benefiting the Lou Ruvo Center for Brain Health and hosted by Larry and Camille Ruvo, co-founders of Keep Memory Alive. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208681513/en/ Baszucki Group and Cleveland Clinic Neurological Institute expand impact of landmark brain study to inv
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