Trending...
- Phinge Exposes Massive AI Security Risks, Claiming Its Patented Hardware-Verified Architecture Is The Only Safeguard Against Surveillance Capitalism
- On the Boards: Proform Builds Announce New Construction in Alki, Seattle
- Phinge's Netverse: Reclaiming the Digital Frontier For Everyone Through CEO Robert DeMaio's Vision of a True App-less, User Data Sovereign World
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
- Gravity Payments and Suno Software Partner to Simplify Payments for Independent Hearing Clinics
- Where Do Missouri Plane Crashes Really Happen? Not Where You'd Think
- Spokane: Female Arrested After Homeowners Caught Her on Property of Burned Home
- SPD Detectives are Investigating a Suspicious Death in West Spokane
- LCC Asia Pacific Sponsors CubeSatPlus 2026 at UNSW Sydney
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
- Spokane: City Council Approves Mayor's Orders for Declaration of Emergency
- Real Estate Syndication Attorney Tilden Moschetti Releases The Real Estate Private Equity Blueprint
- 5X Gross Margin Improvement to Beat EPS Consensus; $54.6 Million 10-Year Contract Award Puts Cybersecurity Leader on Path to a $30 Million Run Rate
- Independent Colbert Packaging Thrives Amid Industrywide Consolidation
- Free Commercial Glass Estimating and Code Compliance Tools Launched by Landmark Construction - The Leading Glass Company in Los Angeles
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
- Space Ambitions Expanding as New Testing Builds on NASA Results and Targets MEO, GEO and Next-Generation Orbital Markets: Ascent Solar Technologies
- FDA Path Clears, Manufacturing Ramps Up + $22.3 Million Strengthens the Balance Sheet; Inflection Point for NRx Pharmaceuticals (N A S D A Q: NRXP)
- Buy Retatrutide Research Peptide: Why Reta Is Getting So Much Attention
- Stage 2 Burn Ban Order in Effect Across Tacoma
- San Diego Attorney Anthony Z. Vargas Narrows Practice to Employment Law, Representing Employees Only
- Spokane: Additional PPE Kits Available Tuesday and Thursday
- Solid Earth Introduces RealtyID, a Universal Identity Spine for the Real Estate Industry
- BlazeHive's AI SEO Agent Outranks Human Writers on 500+ Google Top-3 Results in 5 Months, on Autopilot
- Cracking the Immortality Code: A Human / AI Long-Term Collaboration Working to Achieve Immortality
- On the Boards: Proform Builds Announce New Construction in Alki, Seattle
- On the Boards: Proform Builds Announce New Construction in Gig Harbor
- Phinge Exposes Massive AI Security Risks, Claiming Its Patented Hardware-Verified Architecture Is The Only Safeguard Against Surveillance Capitalism
- Phinge & CEO Robert DeMaio Publicly Declare Cash Settlements or Judgments Alone Cannot & Will Not Remedy the Deep Public Harm of Infringing Its IP
- Dana Flanagan Expands the Authority Architect, Bringing a Nontraditional Approach to Executive Authority, Strategic Access and Business Growth
- Phinge's Netverse: Reclaiming the Digital Frontier For Everyone Through CEO Robert DeMaio's Vision of a True App-less, User Data Sovereign World
- DuraFast Label Company Launches Seiko SLP850 2" Thermal Printer with Free Label Promotion
- Scientific Figure Releases Free Layout Template Libraries for Graphical Abstracts and Research Posters
- Permian Museum announces the addition of an Ancient Alien Artifacts photo gallery
- VISION 2050 Award for Historic Tideflats Subarea Plan Presented by Puget Sound Regional Council at Tacoma City Council Meeting
- The Golden Jazz Fest Shuttle Returns for 2026