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
2026 NAB Show Opens Tomorrow, Uniting Global Media Leaders to Shape the Future of Storytelling18.4.2026 04:08:00 CEST | Press release
CEO of Zhong, one of YouTube’s most-watched creators with 70 million subscribers and 95 million followers on all platforms, joins program The 2026 NAB Show kicks off Saturday, April 18, with the show floor and exhibits opening on April 19, highlighting the most innovative companies and bringing together the world’s most influential voices across media, entertainment and technology for the industry’s premier global event. As the only platform that convenes broadcasters, media companies, content creators and technology innovators at scale, NAB Show continues its century-long legacy as the catalyst for innovation, growth and deal-making in a rapidly evolving, multi-platform world. From artificial intelligence and the creator economy to sports, streaming and cloud transformation, NAB Show is where the tools, talent and ideas driving the future of storytelling converge. “NAB Show is where the global media ecosystem comes together not just to explore what’s next—but to build it,” said Karen
Philip Morris International Announces U.S. FDA Reauthorization of IQOS as a Modified Risk Tobacco Product17.4.2026 23:43:00 CEST | Press release
A pioneer in smoke-free tobacco products, Philip Morris International is the only company that has received modified risk tobacco product authorizations for heated tobacco products.In their order, FDA concluded that: “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals” The U.S. Food and Drug Administration (FDA) announced that it has authorized the renewal of modified risk tobacco product (MRTP) orders previously granted to PMI for two versions of the IQOS device and three variants of the tobacco consumables, commercialized under the HEETS brand. This renewal allows PMI to continue sharing reduced-exposure information with U.S. adults 21+ who use traditional tobacco products, such as combustible cigarettes. The agency concluded that renewing the IQOS and HEETS MRTP authorizations is appropriate to promote public health and is expected to benefit th
Canva Announces Anthropic Collaboration to Bring AI-Powered Design to Millions17.4.2026 17:51:00 CEST | Press release
New collaboration brings Canva into Claude Design by Anthropic, turning AI-generated ideas into fully editable, on-brand designs Canva, the world’s leading all-in-one visual communication platform, today announced the next chapter in its two-year strategic collaboration with Anthropic, bringing Canva directly into the newly launched Claude Design by Anthropic Labs, one day after unveiling Canva AI 2.0 to a crowd of 6,500 people at Canva Create in Los Angeles.. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260410843169/en/ Canva and Claude Canva is also today introducing HTML importing, a new capability that makes it easy to bring interactive content generated in tools like Claude into the Canva editor for drag-and-drop collaboration, refinement, and publishing. The collaboration makes it easier for Claude Design users to turn AI-generated drafts and ideas into fully editable designs in Canva, where they become collaborative
Andersen Consulting tilføjer samarbejdsfirmaet Nuvolar17.4.2026 15:43:00 CEST | Pressemeddelelse
Andersen Consulting udvider sin platform for digitale transformation gennem en samarbejdsaftale med Nuvolar, et teknologikonsulenthus med speciale i cloudbaseret softwareudvikling og avancerede Salesforce-implementeringer. Nuvolar, der blev stiftet i 2008 og har hovedsæde i Spanien, leverer end-to-end digital produktudvikling med dyb ekspertise inden for Salesforce, specialudviklede web- og mobilapplikationer, full-stack udvikling, UX/UI-design, produktledelse og langsigtede supporttjenester. Med mere end 110 fagfolk fordelt over Barcelona, Madrid, Miami og Mexico City arbejder virksomheden med kunder inden for luftfart, sundhedsvæsen, forbrugsgoder, medicinalindustrien samt hotel- og restaurationsbranchen for at designe og implementere skalerbare, forretningskritiske platforme, der optimerer driften og fremskynder den digitale transformation. "Samarbejdet med Andersen Consulting giver os mulighed for at levere vores ekspertise i en større skala," udtalte Marc Vivas, administrerende di
Qualcomm Announces Quarterly Cash Dividend17.4.2026 15:00:00 CEST | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.92 per common share, payable on June 25, 2026, to stockholders of record at the close of business on June 4, 2026. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing business
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