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
Hanshow and the University of Cambridge Launch Joint Research on Augmented Intelligent Hybrid Wireless Technology25.12.2025 12:34:00 CET | Press release
Hanshow, a global leader in electronic shelf labels (ESL) and digital store solutions, has entered into a multi-year research collaboration with the University of Cambridge, one of the world’s most prestigious academic institutions. The partnership will focus on joint research and innovation in next-generation intelligent hybrid wireless technologies, marking an important milestone in Hanshow’s continued investment in core technologies and long-term innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251225988816/en/ This collaboration leverages the University of Cambridge’s deep expertise in fundamental wireless technology research, alongside Hanshow’s extensive industry experience, to further strengthen multi-protocol integration capabilities and expand scalable applications across diverse retail scenarios. Guided by shared principles of innovation, collaboration, openness, and knowledge sharing, the two parties aim
Social Development Bank Highlights Strategic Partnerships and Global Initiatives at DeveGo 202524.12.2025 17:27:00 CET | Press release
The forum held in Riyadh witnessed the signing of 51 agreements aimed at strengthening the entrepreneurial ecosystem The Social Development Bank (SDB) hosted the second edition of the Entrepreneurship and Modern Business Practices Forum, “DeveGo 2025”, from 21 to 23 December in Riyadh. Held under the patronage of His Excellency Eng. Ahmed bin Sulaiman Al Rajhi, Minister of Human Resources and Social Development and Chairman of SDB’s Board of Directors, the forum brings together government leaders, global experts, investors, and entrepreneurs to shape the future of entrepreneurship and modern business practices in the Kingdom of Saudi Arabia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251224036724/en/ From right to left: Ahmed Al Rajhi, Saudi's Minister of Human Resources and Social Development, H.E. Rebeca Grynspan, Secretary-General of UNCTAD, and Sultan Al Hamidi, CEO of Social Development (Photo: AETOSWire) Opening th
Making Science Unveils ‘AWAKE’: The AI Venture Studio Industrialising Startup Creation and AI-First Innovative Solutions23.12.2025 20:51:00 CET | Press release
The disruption generated by AI enables the acceleration and industrialisation of the creation of internal solutions and start-ups through centres of excellence in Chicago, Madrid and Tbilisi.This model has already proven its commercial and innovative power through the acceleration of startups like ad-machina, which has multiplied its value by 10 since joining the Making Science ecosystem. Making Science, the global digital acceleration consultancy, today announced the launch of AWAKE Venture Studio. This "AI-first" model represents a new era in systematic innovation, designed to identify, prototype, and scale both internal proprietary solutions and independent AI-native startups with global reach. The launch of AWAKE is motivated by the significant efficiency gains of orders of magnitude that Making Science has already achieved through the internal integration of AI. By applying these methods, the firm has achieved a 2x acceleration in tech feature development reducing time in the depl
FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia23.12.2025 18:07:00 CET | Press release
Deseyne® (vifilcon C) Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) Delivers Continuous Vision at All Distances—Redefining Presbyopia Correction The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC, a leader in eye health innovation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the first and only Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia utilizing patented Extended Depth of Focus (EDOF) optical design technology, enabling commercial distribution in the United States. Deseyne® delivers smooth, continuous focus across near, intermediate, and distance vision, providing clear, natural vision without compromise. This performance is enabled by Cataltheia’s patented hyper-refractive central zone, engineered to precisely redirect light in a controlled manner. The result is a clear clinical advantage over the only other available contact lens option for presbyopia, multifoc
Aramco Awards SLB Long-Term Contract to Support Kingdom’s Unconventional Gas Production Growth23.12.2025 14:58:00 CET | Press release
Five-year contract to drive innovation in stimulation, intervention, digital and frac automationAgreement underscores gas as a pivotal fuel for global energy demand and a bridge to lower-carbon systems Global technology company SLB (NYSE: SLB) has been awarded a five-year contract by Aramco to provide stimulation services for its unconventional gas fields. This award is part of a broader multi-billion contract, supporting one of the largest unconventional gas development programs globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251223074948/en/ The contract encompasses advanced stimulation, well intervention, frac automation, and digital solutions, which are important to unlocking the potential of Saudi Arabia’s unconventional gas resources. The contract encompasses advanced stimulation, well intervention, frac automation, and digital solutions, which are important to unlocking the potential of Saudi Arabia’s unconve
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