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
From Pilots to Profit: NTT DATA's 2026 Global AI Report Shows How Top Performers Turn AI Vision Into Value8.12.2025 14:00:00 CET | Press release
Study reveals how the top 15% of companies are 2.5x more likely to post >10% revenue growth and over 3x more likely to achieve ≥15% profit margins from AI deployments NTT DATA, a global leader in AI, digital business and IT services, today released the 2026 Global AI Report: A playbook for AI leaders. The playbook is based on the company’s new benchmark research and reveals how “AI leaders” are separating from competitors through strategy and execution. The analysis is based on a survey of 2,567 senior executives across 35 countries and 15 industries. Only 15% of participating organizations qualified as “AI leaders,” defined by clear AI strategies, mature operating models and focused execution. These leaders report significantly higher revenue growth and profit margins than other organizations. “AI accountability now belongs in the boardroom and demands an enterprise-wide agenda,” said Yutaka Sasaki, President and CEO, NTT DATA Group. “Our research shows that a small group of AI leader
AdvanCell Receives First Delivery of High-Activity Thorium-228, Highlighting a Unique Industry Capability and Expertise Essential to Scaling Lead-212 Production for Targeted Alpha Therapies8.12.2025 14:00:00 CET | Press release
Thorium-228 (228Th) is the parent isotope and key starting material to produce the alpha-emitter Lead-212 (212Pb) The established capability to receive and process high-activity 228Th, provides a key competitive advantage in scaling up 212Pb production to support the rapid advancement of 212Pb-ADVC001 (ADVC001) clinical development and the expanding pipeline The received 228Th will be processed into sources for our proprietary generator and installed in production systems first in Australia and subsequently in the US, as part of the planned expansion AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced it has received the first delivery of high-activity 228Th, the parent isotope of 212Pb and a key starting material to produce the alpha-emitter 212Pb, used to manufacture ADVC001, the company’s lead asset, and other 212Pb-based radioligand therapies in the pipeline. This delivery marks a major milestone for the
BRUKINSA Delivers Landmark 74% 6-Year PFS in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia8.12.2025 14:00:00 CET | Press release
Multiple long-term follow-up studies confirm BRUKINSA’s superior efficacy and favorable tolerability versus ibrutinib in relapsed or refractory CLLAdditional ASH data from investigational BTK degrader, BGB-16673, highlight potential first- and best-in-class activity with durable responses in heavily pretreated patients with CLL BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reaffirms its position as the leader in chronic lymphocytic leukemia (CLL) innovation by showcasing the depth, quality, and momentum of its hematology portfolio at the 67th ASH Annual Meeting and Exposition in Orlando, Florida. The totality of BeOne’s ASH data reinforce BRUKINSA® (zanubrutinib) as the foundational Bruton’s tyrosine kinase inhibitor (BTKi) of choice. “At ASH 2025, we will present new data from across our CLL franchise, highlighting both the strength of BRUKINSA and the potential of BGB-16673,” said Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology,
Pink Changing Lives®: Mary Kay Builds 11th Preschool in Sri Lanka, Turning a Dream Into Thousands of New Beginnings8.12.2025 14:00:00 CET | Press release
Each year, Mary Kay supports causes that enrich millions of women’s lives globally, including access to education Mary Kay Inc., a global champion for women’s empowerment, is turning pink into purpose through its Pink Changing Lives® Program to raise awareness and funds to support life-changing programs advancing cancer research, support survivors of domestic violence, protect our planet’s most precious resources, and create opportunities that help women and their families thrive. Since 1996, the multi-faceted Pink Changing Lives® Program has donated over $230 million in monetary and in-kind donations to improve the lives of women and their families in communities around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208554750/en/ Mary Kay Inc., a global champion for women’s empowerment, is turning pink into purpose through its Pink Changing Lives® Program to raise awareness and funds to support life-changing p
IonQ Expands in EU With Slovakia’s First National Quantum Communication Network8.12.2025 13:05:00 CET | Press release
Partnering with the Slovak Academy of Sciences, IonQ bolsters national security and European quantum communications infrastructure IonQ (NYSE: IONQ), the world’s leading quantum company, through its subsidiary ID Quantique (IDQ), today announced the deployment of Slovakia’s first national quantum communication network. Developed in partnership with the Institute of Physics, Slovak Academy of Sciences (IPSAS), the new system features a resilient hybrid architecture designed to strengthen the country’s cybersecurity infrastructure and support Europe’s quantum digital programs. The Slovak Quantum Communication Infrastructure (skQCI) project represents a major milestone in Slovakia’s contribution to the European Quantum Communication Infrastructure (EuroQCI) initiative, which seeks to establish a secure quantum-resistant communication backbone covering all European Union (EU) member states and territories. By integrating quantum-safe technologies at a national scale, Slovakia will directly
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