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
Allianz and Anthropic Forge Global Partnership to Advance Responsible AI in Insurance9.1.2026 10:00:00 CET | Press release
Anthropic’s safety-first AI meets Allianz's dedication to customer centricity, stakeholder trust, and regulatory excellenceThree focus areas of the partnership: workforce empowerment, operations automation through agentic AI, and regulatory compliance Allianz SE and Anthropic today announced a global partnership to accelerate the adoption of responsible Artificial Intelligence (AI) at Allianz. The collaboration centers on three transformative projects within Allianz Group designed to empower Allianz employees and accelerate operations, while setting new benchmarks for accuracy. “With this partnership, Allianz is taking a decisive step to address critical AI challenges in insurance. Anthropic’s focus on safety and transparency complements our strong dedication to customer excellence and stakeholder trust. Together, we are building solutions that prioritize what matters most to our customers while setting new standards for innovation and resilience,” said Oliver Bäte, CEO of Allianz SE.
MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in Mild-to-Moderate Ulcerative Colitis9.1.2026 07:00:00 CET | Press release
MH002 is currently the most advanced Live Biotherapeutic Product (LBP) based on a rationally-designed combination of disease specific bacteria (microbial consortia), for the treatment of inflammatory bowel diseases (IBD) STARFISH-UC Phase 2b trial is designed to confirm MH002’s early efficacy signals and favorable safety observed in Phase 2a studies MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead program MH002. This enables the initiation of the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis, marking a significant step forward in the development of next-generation therapies for inflammatory bowel diseases (IBD). About the STARFISH-UC Phase 2b Trial The STARFISH-UC trial is a randomized, double-blind,
FieldBee Vision wins Gold for Digital Technology Innovation at LAMMA 20269.1.2026 05:25:00 CET | Press release
FieldBee, the European leader in high-quality, easy-to-use and affordable precision agriculture technologies, proudly announces that FieldBee Vision has earned global recognition, becoming the Gold Winner in the Digital Technology Innovation of the Year category at the LAMMA Innovation Awards 2026. Lamma Show is the UK’s premier agricultural machinery, technology and equipment innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260107606411/en/ FieldBee wins the LAMMA Innovation Award 2026 for Digital Technology Innovation of the Year for the FieldBee Vision (VisionSteer & VisionPro) system FieldBee Vision is part of the newly launched myFieldBee ecosystem, built to unify FieldBee’s precision farming tools and designed to connect navigation, autosteering, ISOBUS into one unified platform that supports planning, execution, monitoring and reporting. FieldBee Vision, the first modular retrofit agricultural vision system,
Survey Finds Over 70% of Chinese Doctors Recommend “AI Doctor Services” Like Ant Group’s AQ for Everyday Health Needs9.1.2026 04:31:00 CET | Press release
A recent survey by Life Times, a well-known Chinese public health media outlet, shows that AI doctor services are broadly supported by doctors in China. Among 500 physicians from the country’s top-tier (tertiary) hospitals, more than 70% said they would recommend AI doctor services to patients for everyday health questions and routine health management. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108456917/en/ Ant Group’s AI-native health app AQ is designed to address common, everyday health concerns and support healthy habit formation. Ant Group’s AQ was the most frequently recommended platform in the survey. The latest figures show that, as of January 2026, the app had accumulated 30 million monthly active users and answers over 10 million health-related questions daily, making it China’s leading AI-native health app. AQ—known in Chinese as Ant A-Fu—is an AI-native health app launched by Ant Group in June 2025. Desig
OPPO Joins VVC Advance Patent Pool as a Licensee and Extends HEVC Advance License9.1.2026 03:00:00 CET | Press release
Access Advance LLC and Guangdong OPPO Mobile Telecommunications Corp., Ltd. (OPPO) today announced that OPPO has joined the VVC Advance Patent Pool as a Licensee and renewed its HEVC Advance License. OPPO, one of the world's largest smartphone manufacturers with operations in more than 70 countries, has been a valued participant in Access Advance's HEVC patent pool since 2020, and more recently joined the Advance Video Distribution Patent (VDP) Pool as a Licensor. These latest agreements mark a new milestone in a broad and deepening relationship between the two companies, with OPPO now participating across all three of Access Advance's video codec licensing programs. The VVC Advance Patent Pool licenses patents essential to the VVC/H.266 standard, which delivers remarkable improvement of video compression performance over HEVC, enabling higher-quality video experiences including 4K, 8K, and HDR content with faster downloads and lower latency. The pool currently includes over 4,500 worl
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