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
Biocytogen Announces FDA IND Clearance for Partner NEOK Bio’s NEOK002 Targeting Solid Tumors27.3.2026 01:00:00 CET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner NEOK Bio, Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for NEOK002, an EGFR/MUC1-targeting ADC program for solid tumors. NEOK Bio plans to initiate a Phase 1 clinical study in the second quarter of 2026 and expects to report initial data in 2027. This IND clearance marks an important milestone for NEOK002, an EGFR/MUC1-targeting ADC candidate developed by NEOK Bio and built on a bispecific antibody originally developed by Biocytogen and licensed in 2024. According to NEOK Bio, NEOK002 is being advanced for solid tumors and may offer differentiated efficacy and safety compared with monospecific ADC approaches directed at either target alone. Dr. Yuelei Sh
Spring is in Full Bloom at the Empire State Building with New Festive Experiences, Sweet Treats, and Seasonal Tower Lighting26.3.2026 21:30:00 CET | Press release
Spring is in full swing at the “World’s Most Famous Building.” The Empire State Building (ESB) today announced a vibrant lineup of spring events in NYC, which include special experiences, treat pop-ups, and an iconic tower lighting that captures the joy and color of the beautiful season. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260326216271/en/ Spring is in Full Bloom at the Empire State Building with New Festive Experiences, Sweet Treats, and Seasonal Tower Lighting “The Empire State Building Observation Deck has transformed into a celebration of the season and one of the best things to do in NYC this spring,” said Dan Rogoski, observatory general manager. “Whether it’s views beside our butterfly installation, sweet pop-ups, or a chance to spot the Easter Bunny, there is something special for every visitor.” Flutter of Color: The Empire State Building installed a brand-new photo opportunity on the 86th Floor Observati
Venture Global and Edison Announce Calcasieu Pass Arbitration Settlement26.3.2026 21:15:00 CET | Press release
Today, Venture Global and Edison jointly announced the signature of a commercial agreement for the settlement of the pending arbitration between the two companies concerning the Calcasieu Pass project. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260326559130/en/ Completion of the settlement is expected by the end of Q2 2026, at which point the arbitration will be terminated. The agreement fully resolves the arbitration in its entirety. As part of the settlement, Edison and Venture Global have also agreed to the delivery to Europe of additional cargoes beyond those envisaged under the long-term contract, to support gas supplies primarily to the Italian market. The first delivery is scheduled for May 2026, in Italy, at the Adriatic LNG Terminal. The agreement represents a significant step in strengthening commercial cooperation between the parties and it establishes a foundation for further future deliveries in the context
Reply Recognized as a Microsoft Frontier Partner for Enterprise AI Delivery26.3.2026 19:06:00 CET | Press release
Reply [EXM, STAR: REY] announces it has been recognized as a Microsoft Frontier Partner within the Microsoft AI Cloud Partner Program, earning the Frontier Partner Badge for demonstrating advanced capabilities in delivering AI-first solutions across Cloud & AI Platforms, AI Business Solutions, and Security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260326965586/en/ The recognition reflects Reply’s capabilities across the Microsoft ecosystem, built through the work of its specialized companies – including Aim Reply, Business Elements Reply, Cluster Reply, Root16 Reply, Solidsoft Reply, Valorem Reply, WM Reply and Zest Reply – supporting enterprise organizations in designing, implementing, and operating AI solutions on Microsoft platforms across real-world business scenarios. The Frontier Partner badge recognizes partners that demonstrate advanced AI driven capabilities and meet rigorous badge requirements at the time of
SLB Announces Dates for First-Quarter 2026 Results Conference Call26.3.2026 18:00:00 CET | Press release
SLB (NYSE:SLB) will hold a conference call on April 24, 2026, to discuss the results for the first quarter ending March 31, 2026. The conference call is scheduled to begin at 11:00 a.m. US Eastern time and a press release regarding the results will be issued at 7:00 a.m. US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (833) 470-1428 within North America or +1 (404) 975-4839 outside of North America approximately 10 minutes prior to the start of the call and the access code is 742955. A webcast of the conference call will be broadcast simultaneously at https://events.q4inc.com/attendee/972985185 on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until May 1, 2026, and can be accessed by dialing +1 (866) 813-9403 within North America or +1 (929)
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