Trending...
- Acuvance Appoints Sandeep Sabharwal to Board of Directors, Strengthening Leadership to Support Continued Platform Growth
- Hazel E Hosts Starline Tours Bus to Sonic Desert - A Launch to Coachella
- Keenethics enters the ChatGPT Apps ecosystem as a new growth opportunity for businesses
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
- Nayarit strengthens its position in Mexico's Culinary Elite with 8 restaurants in the 2026 Mexico Gastronomic Guide
- Winter Garden Ski Lake Home Sells for $2.05M in Cash Transaction, Highlighting Demand for Strategically Positioned Luxury Properties
- Strobert Tree Services' "50 Shades of Green" Campaign Encourages Arbor Day Action Across Delaware and Pennsylvania
- As Fluoride Debate Grips the Nation, Americans Turn to Whole-House Fluoride Filters for Answers
- FOCUS Hires Carrier-Side Operations Leader to Build the Next Generation of Insurance Service Delivery
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
- Adams Security Group LLC Launches New Website to Expand Professional Security Services Across Florida
- Presidential Acceleration of Psychedelic Therapies Enters a Defining Moment as Federal Policy, FDA Alignment & Breakthrough Neurotechnology Converge
- Peernovation And Inception Stratos Launch Joint Venture To Build A Global Peer-powered Performance Platform
- GDE Tree Services Expands Operations Across Logan, Ipswich and the Gold Coast
- UK AltNet FullFibre Solves IPv4 Shortage With netElastic BNG And CGNAT Networking Software
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
- Creator Space LA brings together industry leaders for an immersive AI showcase, demonstrations, and film hackathon
- The Hardest Part of Building an App Isn't Starting - It's Finishing
- Uxur Taxi Unveils Luxury 3,000‑Mile Private Driver Service for Nationwide Travel
- Tacoma: Statement from District 4 Council Member Sandesh Sadalge on the Critical Importance of Centering Equity in Regional Transit Decisions
- Seattle Filmmaker Maikaru Launches Mainasty Press with Ambitious "21 Novels in 21 Months" Initiative
- Tacoma: Street Closure Projected to Start the Week of April 20 for Residential Street Restoration Program Maintenance Work
- Colorfront Launches New Mac App For Creating Apple Immersive Video
- Michele Mundy's "Divinely Tailored" Gains Momentum
- Evermore Bliss Launches AI Wedding Speech Writer to Help Users Create Personalized, Heartfelt Toasts
- Keenethics enters the ChatGPT Apps ecosystem as a new growth opportunity for businesses
- Spring Into Your New Home at Heritage at South Brunswick
- UK Financial Ltd Launches UKFL Premier One as Its Official Broadcast Channel for Premium Content, Podcasts & Independent Expert Analysis
- The Great Junk Hunt Returns to Its Roots in Puyallup
- Mayor Anders Ibsen and Council Member Kristina Walker Urge Tacoma Residents to Participate in Sound Transit's Public Survey
- HarryPotterObamaSonic10Inu (Ticker: BITCOIN) Is the Best Cryptocurrency in Global History
- Dual-Engine Growth Strategy Unleashed Targeting a $9.1B Market and the Exploding AI Biotech Revolution: KALA BIO (N A S D A Q: KALA)
- GitKraken Desktop 12.0 Introduces Agent Mode: Gives Developers Ultimate Control & Visualization While Scaling Parallel Agent Workflows
- 5 Things to Check Before Calling for AC Repair in Philly
- Go Dental Clinic Announces Upcoming Opening of New Branch in International City, Dubai
- Hazel E Hosts Starline Tours Bus to Sonic Desert - A Launch to Coachella