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
Redslim expands into Asia-Pacific to support global brands with data and AI infrastructure12.3.2026 07:00:00 CET | Press release
Redslim, a specialist in end-to-end data management solutions and an Astorg portfolio company, today announced its expansion into the Asia-Pacific region and the appointment of Kyriakos Zannikos as Regional Director, APAC. The move marks an important milestone in Redslim’s global growth strategy and brings the company closer to clients operating in one of the world’s fastest-growing and most data-driven consumer markets. As global consumer brands accelerate digital transformation and AI adoption, many organizations still struggle with fragmented data ecosystems spanning multiple agencies, markets and datasets. These challenges are particularly pronounced in Asia-Pacific, where diverse market structures and rapid growth create complex data environments. Redslim helps organizations transform fragmented market information into valuable data assets, empowering clients to make confident decisions and unlock the full value of their data. By building strong data foundations, Redslim supports
Meiji Seika Pharma Initiates Phase I Clinical Trial in Australia Evaluating ME3241, an Anti-PD-1 Agonist Antibody Discovered Through Collaborative Research With FBRI12.3.2026 07:00:00 CET | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Chuo-ku, Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) announced today that it has initiated a Phase I clinical trial of ME3241 (development code), an anti-PD-1 agonist monoclonal antibody discovered through collaborative research with the Foundation for Biomedical Research and Innovation at Kobe (Headquarters: Kobe, Japan; President: Shuh Narumiya; hereinafter “FBRI”). The Phase I clinical trial is designed as a randomized, placebo-controlled, double-blind study, with the objective of evaluating the safety and tolerability of ME3241 following single and multiple dosing, as well as its pharmacokinetics and pharmacodynamics (ClinicalTrials.gov: NCT07422207). ME3241 was discovered through a collaborative research program led by Program Director Tasuku Honjo, a professor emeritus at Kyoto University. PD-1 is a molecule expressed on activated T cells and other lymphocytes that suppresses immune responses. Through this re
Andersen Consulting styrker sin platform med samarbejdsvirksomheden Ambit Iberia12.3.2026 05:55:00 CET | Pressemeddelelse
Andersen Consulting udvider sine kompetencer inden for teknologi og forretningstransformation gennem en samarbejdsaftale med Ambit Iberia, et konsulentfirma, der specialiserer sig i digitale og regulatoriske løsninger til life science-sektoren. Ambit Iberia, der blev stiftet i 2003, har hovedsæde i Spanien og leverer integrerede løsninger inden for rådgivning, teknologi og rekruttering til medicinal-, bioteknologi- og medtechvirksomheder. Virksomheden hjælper kunder med at opfylde skiftende standarder for kvalitet, compliance og lovgivning gennem ydelser, der spænder over regulatoriske anliggender, dataintegritet, validering af it-systemer og digital transformation. Med mere end 20 års brancheerfaring tilbyder Ambit Iberia også ydelser inden for human capital og executive search, der forbinder organisationer med specialiserede fagfolk og topledertalenter, hvilket øger effektiviteten og fremmer bæredygtig vækst i et stærkt reguleret miljø. "Vores fokus har altid været at levere speciali
EIG’s MidOcean Energy to Acquire Additional Gorgon LNG Interest from JERA; Parties Explore Strategic Alliance12.3.2026 03:14:00 CET | Press release
Transaction increases MidOcean’s equity exposure to premier Australian LNG project Adds incremental uncontracted LNG volumes, enhancing portfolio optimization and marketing flexibility Planning future collaborations, exploring further transactions and opportunities with JERA across other assets globally with the aim of creating a future strategic alliance MidOcean Energy (“MidOcean”), a liquefied natural gas (LNG) company formed and managed by EIG, today announced it has entered into definitive agreements with JERA Co., Inc. (“JERA”) to acquire JERA Gorgon Pty Ltd, which holds JERA’s 0.417% interest in the Gorgon LNG project. MidOcean is an existing participant in the Gorgon LNG project, and this transaction increases MidOcean’s interest in Gorgon to 1.417%. The transaction perimeter also includes JERA’s 0.735% interest in the Ichthys LNG project. Subject to the satisfaction of relevant conditions precedent, the interests in Gorgon and Ichthys will be sold to MidOcean, and then the Ich
DCX Launches Comprehensive ECDU Portfolio – Enterprise-Class Coolant Distribution Units From 600 kW to 2.6 MW11.3.2026 16:34:00 CET | Press release
DCX Liquid Cooling Systems today unveiled its new ECDU (Enterprise Coolant Distribution Unit) platform, a family of three purpose-built CDU models that deliver real cooling capacities from 600 kW to 2.6 MW in industry-standard rack and in-row footprints. The portfolio has been engineered specifically for the accelerating transition to direct-to-chip liquid cooling in high-density enterprise, colocation, cloud, and hyperscale AI environments where thermal stability, uptime, and cost-efficiency are non-negotiable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311214891/en/ DCX ECDU, the new generation of Enterprise Coolant Distribution Units dedicated to HPC and AI deployments. The lineup consists of: Enterprise ECDU 1380/2600 V1 - Delivers 1.38–2.6 MW of actual cooling capacity (based on real-world secondary-loop conditions). Single-pump configuration reaches flow rates up to 3,333 liters per minute (lpm). Mission Critica
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