Trending...
- Spokane: SFD's 8th Annual Kids Jr Firefighter Academy
- OneVizion Launches Vera AI, Bringing Connected Operational Context to Infrastructure Teams
- Applicants Sought for the Tacoma Arts Commission and the Tacoma Creates Advisory Board
SEATTLE--(BUSINESS WIRE)--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."
More on Washingtoner
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.
More on Washingtoner
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.
Contacts
Nick McDonald
AGC Biologics
nmcdonald@agc.com
(425) 419-3555
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."
More on Washingtoner
- Fashion vs. Fascism - Because Democracy Should Always Be In Style
- Lee Gunn IV Shares Lessons From 40 Years in the Courtroom on PodNumbra Podcast
- Michael H. Kaplan Recognized for 17 Years on PHPA Workers' Compensation Panel and Advocacy for Professional Athletes
- City of Spokane Announces New Tools, Resources to Support Fire Recovery and Rebuilding
- Tacoma Residents Invited to Turn Recycled Glass Into Art Through New Pilot Program
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.
More on Washingtoner
- International Society of Medical AI Convenes Global Faculty in Florence for ISMAI 2026
- Boston Industrial Solutions Introduces Personalized Printing Training
- Century Fasteners de Mexico Exhibiting at the 2026 Automotive & Aerospace Nearshoring Summit
- Spokane: Funding Available for Tourism and Culture Investment Grants
- Retell AI White Label Platform for Agencies Launched by VoiceAIWrapper, With Branded Client Portals and No Per-Minute Markup
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.
Contacts
Nick McDonald
AGC Biologics
nmcdonald@agc.com
(425) 419-3555
0 Comments
Latest on Washingtoner
- Super Rooter Expands to 190 Plumbing, Sewer, and Drain Service Locations Across the United States
- European Patent for ALS Program Expands the Story: HOPE Deploys Robotic TMS & FDA Commercialization Path Advances: NRx Pharmaceuticals: NAS DAQ: NRXP
- VICTURY Sports Announces Formation of Youth Sports League Built on the Official, Patented, and Award-Winning Keepy Uppy® Ball
- Congressman Chuck Edwards (NC-11) Presents ReadyCommunities Partnership 2026 National Service Award to Local Businessman / US Air Force Veteran
- Cress Creeks Farm Opens Fall Corn Maze and Baby Lamb Hayride Experience in Ellijay, Georgia
- Allstream Energy Partners Nominated in Multiple Categories for Fast Company's Best Workplaces for Innovators
- Pebble Photo Booths Brings Modern Photo Experiences to Vancouver, Washington
- Spokane: Flags at Half-Staff in Remembrance of 9/11 Victims
- Haven Treatment Center Now In-Network with First Choice, Expanding Access to Youth Health
- Kerri Lawless Introduces New Home-Selling Option for Local Homeowners
- FDA-Cleared Zeta TMS Robotic System Moves Toward Deployment as FDA, DARPA and Commercial Catalysts Converge: NRx Pharmaceuticals (N A S D A Q: NRXP)
- Baird Medical Turns Global Expansion Into Tangible Growth: N A S D A Q: BDMD Posts 25% Revenue Surge as U.S. and International Markets Accelerate
- City of Spokane Launches 'Emergency Streets' Pilot Program
- Spokane: City Seeks Feedback on Future Land Use Map
- Shelter Structures America makes European debut at TEMPOR EXPO 2026 in Fulda, Germany
- Longevity Academy Announces J.P. Medved of Longevity Advice as Next Guest in the Longevity Leaders
- Medcurity Introduces a Better Way for Healthcare and Its Vendors to Build Trust
- Haven Treatment Center Now In-Network Partnership with Aetna, Expanding Access to Youth Health Care
- Applicants Sought for the Tacoma Arts Commission and the Tacoma Creates Advisory Board
- Spokane City Council Approves Emergency Tenant Protections