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
Arboris Capital Selects ROYC to Expand Private Markets Capabilities on CapGain Platform18.5.2026 09:00:00 CEST | Press release
Arboris Capital Limited (“Arboris”), a DIFC-based firm arranging alternative investments, authorised by the Dubai Financial Services Authority (DFSA), today announced that it has selected ROYC AB (“ROYC”), a private markets technology and infrastructure provider, to support the continued development of its private markets offering through its platform, CapGain. In its ongoing efforts to expand its private markets capabilities across the Middle East, Arboris has undertaken a strategic review of how to further scale its offering while maintaining the integrity of its existing platform. As a result, Arboris has chosen to integrate ROYC’s fund access, sourcing, and structuring capabilities into CapGain, complementing its existing infrastructure. CapGain is Arboris’s proprietary investment platform, purpose-built to facilitate access between international private market opportunities and Professional Investors in the region. CapGain provides fully digital investor onboarding and KYC, a secu
OdysseyRe Announces New Co-Chief Underwriting Officers for EMEA18.5.2026 09:00:00 CEST | Press release
Odyssey Reinsurance Company (OdysseyRe) today announced the appointments of Tegwen Gromellon and Anne-Claire Serres as co-chief underwriting officers of its EMEA division, effective July 1. They succeed longtime Chief Underwriting Officer, Gaël Le Païh, who is retiring later this year following 36 years with the Company. Based in Paris, Serres joined OdysseyRe in 2018 as the market director for France and will lead the division’s business across France, Africa and the Middle East. Gromellon, who joined OdysseyRe in 2004, has served as market director for Germany, Austria, Benelux and Switzerland since 2019. He will take the lead for the rest of Europe, including the relationship with the Company’s representative office in Stockholm for the Nordic markets and across Turkey. “We are delighted to appoint both Tegwen and Anne-Claire to these important leadership positions,” said Isabelle Dubots-Lafitte, chief executive officer of EMEA for OdysseyRe. “These appointments recognize their sign
LogicMonitor and Deutsche Telekom Expand Partnership Across Europe18.5.2026 09:00:00 CEST | Press release
Expanded availability of LogicMonitor within Deutsche Telekom’s managed services portfolio follows successful operational use in the UKSelect outcomes include reduced reporting times and proactive incident preventionExpansion extends across DACH, Benelux, and the Nordics LogicMonitor®, the AI-first platform for Autonomous IT, today announced the expanded availability of its platform within Deutsche Telekom’s managed services portfolio across selected European markets, including DACH, Benelux, and the Nordics. The expansion builds on operational use of LogicMonitor in the United Kingdom since 2023, where it has supported Deutsche Telekom’s service teams in improving visibility across network, cloud, and hybrid infrastructure environments. Experience gained from these deployments is now informing broader service enablement across additional European markets. As enterprise IT environments grow more complex, organisations require more than visibility—they need predictive resilience. Throug
Prokarium Reports Positive Interim Data from Phase 1/1b PARADIGM-1 trial of ZH9 in NMIBC patients, Demonstrating Excellent Safety and Encouraging Early Efficacy18.5.2026 09:00:00 CEST | Press release
ZH9 is very well tolerated with a favourable safety profile, and no dose-limiting toxicities or Grade ≥3 drug-related adverse events reported.ZH9 demonstrates 91% freedom-from-relapse in NMIBC patients who have reached study end.Company plans to run a larger phase 2 study across a range of patient populations spanning intermediate risk and high risk including CIS. Prokarium, a clinical-stage biopharmaceutical company pioneering bacterial immunotherapies for the treatment of solid tumours, today announced safety and antitumour efficacy results from an interim review of the ongoing Phase 1/1b PARADIGM-1 trial of ZH9 in non-muscle invasive bladder cancer (NMIBC) patients. These data were shared via an oral podium presentation at the American Urology Association (AUA26) Annual Meeting. Prokarium CMO, Dr Josefin-Beate Holz said “These data demonstrate ZH9 as a universally applicable treatment for patients. As the treatment is very well tolerated and is showing impactful outcomes for early a
VahatiCor Appoints Harry D. Rowland, Ph.D., as Chief Executive Officer18.5.2026 08:00:00 CEST | Press release
Endotronix co-founder and former CEO joins VahatiCor as the company advances the A-FLUX Reducer System® and the SERRA-I early feasibility study VahatiCor, Inc., a medtech company developing interventional therapies for Coronary Microvascular Dysfunction (CMD), announced today the appointment of Harry D. Rowland, Ph.D., as Chief Executive Officer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260517830314/en/ VahatiCor CEO, Harry D. Rowland, Ph.D. Rowland previously served as Chief Executive Officer and President of Endotronix, where he led the development and commercialization of the Cordella™ Pulmonary Artery Sensor and Heart Failure System. Under his leadership, Endotronix raised over $150 million and grew to more than 150 employees. He also oversaw the PROACTIVE-HF pivotal trial from execution through FDA premarket approval and commercial launch. Following its acquisition by Edwards Lifesciences in 2024, Rowland stayed o
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