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
“And I Chose to Live” The Blind Sailor Mitsuhiro Iwamoto Takes the Stage at WEF23.1.2026 09:00:00 CET | Press release
- “HIRO’s CHOICE”: A Solo, Non-Stop Crossing of the Pacific Ocean- Mitsuhiro Iwamoto, a blind Japanese sailor based in San Diego, delivered a speech at the World Economic Forum Annual Meeting 2026 on January 21 (local time). He is undertaking the world’s first solo, non-stop trans-Pacific crossing by a blind person as part of the “Blind Sailor Single-Handed Pacific Crossing Project 2027.” WEF URL: https://www.weforum.org/ This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260121469502/en/ Hiro Iwamoto / Global Keynote Speaker, First Totally Blind Sailor to Cross the Pacific In the spring of 2027, he will attempt a solo, non-stop trans-Pacific crossing, sailing a 28-foot yacht single-handedly from San Diego on the U.S. West Coast to Amakusa, Kumamoto Prefecture, Japan, without making any port calls. Project URL: https://hiros-choice.com/ The theme of his speech was “Sailing Through Barriers.” He spoke about how, since losing his
BitGo Holdings fejrer sin børsnotering på New York Stock Exchange23.1.2026 03:52:00 CET | Pressemeddelelse
BitGo Holdings, Inc. ("BitGo", "virksomheden", "vi"), en virksomhed inden for digital infrastruktur til aktiver, fejrer i dag sin lancering på New York Stock Exchange ("NYSE") som et børsnoteret selskab under tickersymbolet "BTGO". Medlemmer af BitGos ledelsesteam vil i dag kl. 09:30 ET ringe med åbningsklokken på NYSE. "I dag markerer et afgørende øjeblik for BitGo," udtaler Mike Belshe, administrerende direktør og medstifter af BitGo. "Vores indtræden på de offentlige markeder vil gøre det muligt for os yderligere at accelerere det finansielle systems overgang til en gennemsigtig og troværdig digital aktivøkonomi, samtidig med at vi fortsat kan levere enestående sikkerheds-, depot- og likviditetsløsninger til vores kunder. Vi er overbeviste om, at potentialet forude er stort, og at vi er unikt positioneret til at hjælpe institutioner med at gå fremtiden i møde." Belshe fortsætter: "Jeg er utroligt stolt af den virksomhed, vi har opbygget, og dybt taknemmelig for vores teams hårde arb
Tinaba with Banca Profilo Strengthens Its Global Positioning and Launches Digital Payments in the Chinese Mainland with Alipay+23.1.2026 02:41:00 CET | Press release
Through the “Pay Worldwide with Alipay+” feature available in the App, users can pay in the Chinese mainland at over 80 million merchants Tinaba with Banca Profilo announces the launch of digital payments in the Chinese mainland through the extension of its strategic partnership with Alipay+, Ant International’s global wallet gateway solution, bringing a simple, cashless and local payment experience to Italian travellers in the world’s largest digital market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260122062969/en/ Matteo Arpe, President of Tinaba with Banca Profilo, announces the expanded partnership with Alipay+ in Milan, Italy Starting today, users can pay in the Chinese mainland at over 80 million merchants simply by scanning a QR code directly from the Tinaba App. This innovation is particularly significant in a country where digital payments are the everyday standard and cash is increasingly less used. The servi
Andersen Consulting indgår samarbejde med Africa International Advisors22.1.2026 22:10:00 CET | Pressemeddelelse
Andersen Consulting udbygger sine kompetencer inden for strategi og forretningstransformation i Afrika gennem en samarbejdsaftale med Africa International Advisors (AIA), en Johannesburg-baseret virksomhed, der fokuserer på at forbedre virksomheders konkurrenceevne gennem sektorspecifik indsigt, innovation og rådgivning. AIA blev stiftet i 2002 og er et panafrikansk managementkonsulentfirma, der leverer strategibaserede rådgivningsydelser med fokus på digital transformation og ai-drevne forretningsresultater. Firmaet rådgiver kunder på tværs af sektorer, herunder energi og ressourcer, olie og gas, infrastruktur, handel og logistik, finansielle tjenesteydelser, bankvæsen og telekommunikation. AIA's strategiske perspektiv, lokale troværdighed og markedsadgang gør det muligt at udvikle og implementere løsninger, der samkører mennesker, processer og teknologi med henblik på at skabe meningsfuld forandring. "Vores mission har fra begyndelsen været at fremme udviklingen gennem en Afrika-cent
iQmetrix Announces First-Ever "Telecom Retail Summit" at MWC Barcelona 202622.1.2026 19:48:00 CET | Press release
Leading software provider challenges the industry on the growing disconnect between telecom innovation and the store experience. iQmetrix, the only global provider of Interconnected Commerce solutions for telecom retail, today announced its return to Mobile World Congress (MWC) Barcelona with the first-ever Telecom Retail Summit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260122446809/en/ As the industry converges for MWC Barcelona 2026, iQmetrix prepares to host the first-ever Telecom Retail Summit, transforming the conversation from network intelligence to the intelligent storefront. The exclusive half-day summit designed to spark an overdue conversation: telecom sells the most advanced technology on earth, yet delivers one of the least inspiring retail experiences in modern commerce. Bringing together telecom industry leaders, futurists, and retail innovators, the Telecom Retail Summit challenges the industry to rethi
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