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
Compass Pathways to Participate in Two Investor Conferences in December20.11.2025 12:30:00 CET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in the following December investor conferences: 8th Annual Evercore Healthcare Conference – Coral Gables, FL: Fireside chat at 10:00am ET on December 2, 2025 Piper Sandler 37th Annual Healthcare Conference – New York, NY: Fireside chat at 1:30pm ET on December 3, 2025 A live audio webcast of these events will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatment
NIQ Achieves Certification as Google Meridian Partner20.11.2025 12:00:00 CET | Press release
Certification strengthens NIQ’s position as a global leader in media outcomes measurement. NIQ, a leading consumer intelligence company, is proud to announce its certification as a Google Meridian partner, enabling NIQ to utilize Google’s open-source marketing mix models to measure marketing impact for advertisers. This achievement underscores NIQ’s commitment to delivering transparent and actionable outcome measurement solutions that help advertisers evaluate and optimize their marketing investments worldwide. Google's Meridian is an open-source Marketing Mix Model (MMM) designed to help businesses measure marketing effectiveness and optimize ad budgets across various media channels. By joining a select group of certified partners, NIQ is collaborating with Google to advance outcome measurement standards and introduce new innovations that complement NIQ’s proprietary MMM solution - helping make high-quality measurement more accessible to marketers everywhere. New Meridian innovations
BeOne Medicines Showcases Leadership in B-cell Malignancies at ASH 202520.11.2025 12:00:00 CET | Press release
BRUKINSA now demonstrates best-in-class sustained efficacy and long-term benefit with a favorable safety profile over more than six years of follow-up data in treatment-naïve and R/R CLLFirst results from Phase 1/2 sonrotoclax monotherapy study will demonstrate notable speed and depth of clinical responses in patients with R/R MCL, a rare, aggressive cancerNew efficacy and safety data will highlight the benefits of potential first-in-class BTK degrader BGB-16673 in patients across multiple hematological malignancies BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, advances its vision to become the world’s leading oncology company with extensive new data from its differentiated hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida, December 6-9. Nearly 50 abstracts have been accepted, including six oral presentations, featuring the company’s three transformative approved and investi
ZKB in Switzerland Completes ISO 20022 Migration Using Smartstream for Reconciliations20.11.2025 11:40:00 CET | Press release
Key Facts Zürcher Kantonalbank (ZKB) can now process ISO 20022 reporting messages ahead of the global SWIFT deadline, going live with Smartstream’s Corona MX solution as part of the Smart Reconciliations suite. The migration, executed in close collaboration with Smartstream and supported by ZKB’s ISO 20022 expertise, enhances the bank’s reconciliation capabilities, particularly for cash transactions across multi-account and currency operations. This strategic move strengthens ZKB’s commitment to innovation and compliance, enabling full payment lifecycle visibility and positioning the bank for future operational excellence. Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces, Zürcher Kantonalbank (ZKB), the largest cantonal bank in Switzerland, has successfully completed its ISO 20022 migration project for reporting messages, now live with Corona MX - part of the Smart Reconciliations solutions suite. This milestone
PUMA Partners with Logistics Reply to Accelerate AI-Driven Innovation in Warehousing20.11.2025 11:00:00 CET | Press release
Logistics Reply, the Reply group company specialising in innovative supply chain, has extended its collaboration with global sportswear brand PUMA to further optimise daily logistics operations and enhance user experience through the integration of GaliLEA, an AI-powered assistant built on the LEA Reply™ platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120676732/en/ Thanks to GaliLEA, PUMA has seen significant improvements in their daily use of the LEA Reply WMS, including increased user autonomy with less reliance on external support, faster management through quick data access and assisted ticket creation, real-time operational insights for better decision-making, and streamlined logistics workflows that enhance overall system interaction. Following the successful rollout of the LEA Reply™ Warehouse Management System (WMS) across four key distribution centers in Austria, South Africa, and India between 2022 and
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