Trending...
- Phinge CEO Ranked #1 Globally by Crunchbase for the Last Week, Will Be in Las Vegas Jan. 4-9, the Week of CES to Discuss Netverse & IPO Coming in 2026
- City of Spokane Seeks Applicants for Park Board
- South Spokane Standoff Ends Peacefully After Suspect Surrenders to Officers
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
- Spokane: Shoplifting Blitz Nets Multiple Arrests as SPD Works to Curb Retail Thefts; Emphasis Continues as Christmas Approaches
- Haven Treatment Center Licensing Delays by Washington State Impeding Mental Health Access
- Tacoma: Update in SR-509 Fatal Collision Investigation: Vehicle of Interest Impounded
- Sexual Assault Suspect That Fled Spokane Area, Arrested in Connecticut; Extradition to Washington State Pending
- Spokane Police Department and SPD Cadets Engage with the Logan Community to Discuss Crime Prevention in the Neighborhood
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
- Mauritania's Cissé Boide Selected as the 2025 Ambassador of the Year
- Guests Can Save 25 Percent Off Last Minute Bookings at KeysCaribbean's Village at Hawks Cay Villas
- Trump's Executive Order Rescheduling Cannabis: Accelerating M&A in a Multibillion-Dollar Industry
- Genuine Hospitality, LLC Selected to Operate Hilton Garden Inn Birmingham SE / Liberty Park
- Documentary "Prescription for Violence: Psychiatry's Deadly Side Effects" Premieres, Exposes Link Between Psychiatric Drugs and Acts of Mass Violence
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
- Proform Builds Completes Two Luxury Seattle Waterfront Renovation Projects
- "Micro-Studio": Why San Diegans are Swapping Crowded Gyms for Private, One-on-One Training at Sweat Society
- City of Spokane Seeks Applicants for Park Board
- South Spokane Standoff Ends Peacefully After Suspect Surrenders to Officers
- Beycome Closes $2.5M Seed Round Led by InsurTech Fund
- City of Vancouver Delaying Haven Treatment Center Facility's Certificate of Occupancy
- City of Spokane, Spokane County, Spokane Regional Emergency Communications Approve Interlocal Agreement to Support Safe, Coordinated Transition of Emergency Communication Services
- Tru by Hilton Columbia South Opens to Guests
- Christy Sports donates $56K in new gear to SOS Outreach to help kids hit the slopes
- "BigPirate" Sets Sail: A New Narrative-Driven Social Casino Adventure
- Phinge CEO Ranked #1 Globally by Crunchbase for the Last Week, Will Be in Las Vegas Jan. 4-9, the Week of CES to Discuss Netverse & IPO Coming in 2026
- Plainsight Announces Jonathan Simkins as New CEO, Succeeding Kit Merker
- Women's Everyday Safety Is Changing - The Blue Luna Shows How
- Microgaming Unveils Red Papaya: A New Studio Delivering Cutting-Edge, Feature-Rich Slots
- RollCraft Launches Pre-Roll Automation Machines for Producers Scaling Production in 2026
- Spokane: Simple Police Contact for a Civil Bike Infraction Ends in Arrest After Suspect Flees from Officers; Stolen Property Recovered After Suspect is Taken into Custody
- 5-Star Duncan Injury Group Expands Personal Injury Representation to Arizona
- The End of "Influencer" Gambling: Bonusetu Analyzes Finland's Strict New Casino Marketing Laws
- AI-Driven Cybersecurity Leader Gains Industry Recognition, Secures $6M Institutional Investment, Builds Momentum Toward $16M Annual Run-Rate Revenue
- TRIO Heating, Air & Plumbing Now Ranks #1 in San Jose