Trending...
- $40 Billion Global Market Value by 2030 Projected in Unmanned Aerial Vehicle or Other Drone Technology Sector, Growing at 9.2% Compound Annual Growth
- Tacoma City Council Expresses Opposition to Initiative Measure No. IL26-001 and Initiative Measure No. IL26-638
- Socialhose Eyes Southeast Asia and Rejects the Copy-Paste Expansion Playbook
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
- Michael M. Thomas Expands Executive Leadership Across Central India Outreach and Royal Trinity School
- Northeast Airlines and Travel, Inc. Initiates FAA Part 121 Certification for Boeing 737-800 Freighter Cargo Operations
- Walker's Realty and North Jersey Properties Introduce Extraordinary Luxury Estate for Rent in West Orange, New Jersey
- Extreme Heat Strains Home Appliances: Appliance EMT Offers "Summer Rescue" Relief
- Independent West Texas Metal Multi-Instrumentalist & Producer. "MAD CHAD™" Russell Surpasses 1.9 Million Project Interactions Via DFGS Productions
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
- No Download Needed: Goosechase Adds Browser Play to Every Experience
- iCustoms launches iWarehouse, an AI bonded warehouse platform for customs and excise storage
- Spokane: City Council Members Commends Unified Wildfire Response
- National Night Out in Spokane Cancelled Due to Wildfire Conditions
- Haven Treatment Center Achieves IMD Certification, Expanding Access to Residential Care
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
- ImagineX Acquires Payteros to Strengthen Digital Transformation Capabilities
- From Pizza to Playlists: Marty The Pizza Guy Delivers Three Delicious New Songs
- Spokane: Mayor Brown looks to expand access to cooling resources
- Spokane: Mayor Brown Launches Data Center Work Group Following Adoption of One-Year Moratorium
- Spokane City Council Passes Renters Right to Cooling Ordinance
- Salestrics Introduces PraiseEngine: The AI-Native Review Engine Built to Fix Social Proof
- K2 Integrity Names Michael Kallabat Global Head of Investigations and Disputes
- Socialhose Eyes Southeast Asia and Rejects the Copy-Paste Expansion Playbook
- $40 Billion Global Market Value by 2030 Projected in Unmanned Aerial Vehicle or Other Drone Technology Sector, Growing at 9.2% Compound Annual Growth
- Tacoma City Council Expresses Opposition to Initiative Measure No. IL26-001 and Initiative Measure No. IL26-638
- As the FCC Router Ban Creates a National Supply Chain Crisis, Haawke Hash Offers the Infrastructure
- Spokane: Second-Alarm Brush Fire Contained at People's Park
- $620 Million in Recent Government Contract Awards with More Than $1.2 Billion in Annualized Revenue: Circle8 Group (N A S D A Q: CIRC)
- Lewis County Hydrogen Alliance Launches Phase 1 Work to Turn Forest Residuals into Fuel-Grade Hydrogen and Dispatchable Clean Power
- Next Gen Fibre Selects netElastic vBNG and CGNAT to Fuel Rapid Nationwide Expansion and Eliminate Network Bottlenecks
- Boston Industrial Solutions, Inc. Introduces SAP-G70 Primer for bonding silicone to silicone and other materials
- Tacoma: Capital Ready: Preparing Businesses for Growth in Public Contracting Workshop on August 26, 2026
- Final Week for Spokane Falls Boulevard Survey
- 'Reflections: Enlightening Insights Into the Divine Mystery' — The Latest Book by Philosopher Steven Colborne
- Scott G. Hoy of Hoy Law Earns 11th Consecutive Super Lawyers Selection