WA-AGC-BIOLOGICS
24.1.2023 14:57:36 CET | Business Wire | Press release
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
Quectel Expands Combo Antenna Portfolio with Rugged Multi-network Solutions for Demanding IoT Deployments25.6.2026 10:00:00 CEST | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, has expanded its external antenna portfolio with four new combo antennas designed to simplify deployment of connected devices across smart cities, fleet management, industrial automation, utilities, public safety and transport applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625825719/en/ Quectel expands combo antenna portfolio with rugged multi-network solutions for demanding IoT deployments The new YEMA206J1AM, YEMA301J1AM, YEMN308L1BM and YENA00L5AH antennas combine cellular, Wi-Fi and GNSS technologies in rugged, compact form factors that help engineers accelerate product development while ensuring reliable connectivity in demanding outdoor and industrial environments. Featuring IP67-rated enclosures, high inter-antenna isolation, flexible mounting options and support for multiple wireless standards, the antennas provide a versatile so
Safe Software Appoints Nabil Lodey as Its First EMEA Senior Executive to Drive Regional Expansion25.6.2026 10:00:00 CEST | Press release
Nabil Lodey joins as VP EMEA to lead Safe Software's expansion across the region, bringing deep geospatial industry expertise and an established network across the partner and customer ecosystem. Safe Software (Safe), creator of FME, the only All-Data, Any-AI enterprise integration platform, today announced the appointment of Nabil Lodey as VP EMEA, where he will drive growth in the company's presence and customer base across the region. His appointment builds directly on Safe's operational expansion into the UK and Ireland, announced in June 2025. Nabil joins Safe from 1Spatial, a long-standing Safe partner and FME reseller, where he served as Managing Director for the UK and Ireland. He brings a deep, first-hand understanding of Safe's business and of the FME Platform, having worked closely with the technology and its customer base. That familiarity positions him to further accelerate Safe's regional expansion plan while deepening the company's commitment to support clients and partn
Floward Scales Customer Service to Handle 13x Peak Demand With Infobip AgentOS25.6.2026 10:00:00 CEST | Press release
AI-powered customer service enables seamless experiences during peak seasons Global AI-first cloud communications platform Infobip has partnered with Floward, the leading online flower and gifting company in the Middle East and the UK, to transform customer service using AI agents on Infobip’s AgentOS platform. By moving beyond traditional rule-based chatbots to agentic AI, Floward now handles up to 13x higher peak-day conversation volumes while maintaining fast response times and high customer satisfaction. As a same-day delivery business built around major occasions such as Mother’s Day, Valentine’s Day, and Ramadan, Floward experiences intense seasonal demand spikes. Working with Infobip’s AI consultants, Floward redesigned its customer journeys on Infobip AgentOS, deploying a multi-agent system that intelligently routes conversations to specialized AI agents for tasks such as address collection, FAQs, and order changes, with seamless escalation to live agents when needed. A key inn
ISC 2026: KAYTUS Unveils Gigawatt-Scale AI Infrastructure and Intelligent Management to Empower Europe’s AI Future25.6.2026 09:02:00 CEST | Press release
End-to-end, fully factory-prefabricated modular AI Factory deployment in just a few months, with full-stack intelligent management from GPU to rack, to the entire data center. KAYTUS, a leading provider in AI infrastructure and liquid cooling solutions, unveiled two core solutions at ISC 2026, designed for next-generation AI data centers: a gigawatt-scale, fully prefabricated containerized liquid-cooled data center solution and KSManage Ultra, an intelligent operations management platform for AI Factories. Together, the solutions target the escalating efficiency, performance, scalability, and reliability requirements of AI-era infrastructure, enabling faster deployment, optimized thermal management, and unified operations across large-scale AI computing environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625809392/en/ KAYTUS prefabricated containerized liquid cooled data center solution The KAYTUS gigawatt-scale
LR Health & Beauty SE Successfully Completes Financial Realignment – Strong Foundation for Growth and Long-Term Partnerships25.6.2026 09:00:00 CEST | Press release
Successful completion of the financial realignment enables full focus on growth and further strengthening operational excellence Planned investments in production and logistics will enhance efficiency, flexibility, and delivery capabilities Further international growth, including expansion into new markets, targeted LR Health & Beauty SE, Europe’s leading social commerce company for high-quality nutritional supplements and beauty products, has successfully completed its financial realignment, establishing the foundation for the company’s stable and forward-looking development. With the achievement of the final milestone, an intensive and demanding process has been successfully concluded. LR has fundamentally realigned its financing structure and significantly strengthened its capital base. An initial financing tranche of EUR 10 million was provided at the end of March, followed by a second tranche of the same amount in June. Jörg Körfer, CEO of LR Health & Beauty SE, comments: “The pas
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