Trending...
- Max Tucci Makes His Highly-Anticipated Debut On QVC—unveiling A Bespoke Luxury Chocolate Collection Inspired By 100 Years Of Tucci Hospitality
- Spokane Police Department Continues To Bolster The Neighborhood Resource Officer Program
- Spokane: Phone Video Of Abduction/Assault Of Teen Leads To Multiple Arrests
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
- Sleep Basil Curates a Clearer Brooklyn Bedding Experience for Performance-Minded Denver Sleepers
- Spokane City Council Members Introduce "Immigration Enforcement Free Zones"
- Spokane: Mayor Brown Calls on Congress to Extend Temporary Protected Status for Haitian Community Members
- Nevada Man Launches Nationwide Animal Abuse Registry
- New Threat Management Workshop Brings Hands-On BTAM Training to Spokane Valley
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
- Star-powered Kappa Takeover Weekend Returns to the DMV June 18- 21, 2026, Hosted By Comedian Joe Clair W/ Dj Quick Silva (the Party Kingpin)
- Tacoma: Homicide Investigation – 1200 Block of South I Street
- Welfare Check Leads To Domestic Violence Arrest; Guns and Drugs Recovered At North Spokane Apartment
- Scoop Social Co. Wins The Knot and WeddingWire Awards as Brand Expands Nationwide
- Denise Murphy Lenci Promoted to Century Fasteners Corp. – General Manager, Northeast Sales
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
- Eagle Americas Expands Into the Western U.S. With High West Machine Tool
- Tacoma: Street Closures Projected to Start the Week of February 9 for Residential Street Restoration Program Maintenance Work
- City of Tacoma Launches Regional Driver Safety Campaign to Support Safer Streets
- Desert Mountain Club Earns Prestigious Blue Zones Approved™ Triple Designation, a New Standard for Well-Being in a Luxury Lifestyle Community
- Outsports announces record-breaking number of LGBTQ+ athletes at 2026 Milan Winter Olympics
- Sheffield Clinic Highlights Safe, Inclusive Laser Hair Removal While Improving Access
- Appliance EMT Partners with Kids Motel Ministry in Metro Atlanta
- CNCPW Divulga Dados de Liquidez do 1º Trimestre: Confirma 100% de Reservas e Atualiza Protocolos de "Saque CNCPW" Contra Fluxos Ilícitos
- Tech Workers Are Escaping "Forever Layoffs" By Becoming Their Own Boss
- Spokane: Phone Video Of Abduction/Assault Of Teen Leads To Multiple Arrests
- Spokane Receives $200,000 Grant from U.S. Conference of Mayors to Support Youth Wellness Zone
- Heritage at South Brunswick Celebrates First Home Closing and Strong Sales Momentum
- Tacoma: 'Bonding Basics' Workshop on February 19
- WinkBeds High-Performance Hybrid Mattresses Debut at Sleep Basil Denver With In-Store Comfort Testing
- Tampa Nonprofit Expands Recovery Services for Men in Crisis With New Farm Program in Plant City
- Applications for 2026-2027 Tacoma Creates Funding Now Available
- Spokane Police Investigating Shooting In North Spokane That Left One Adult Injured
- IYKYK! Coffee Lab Thriving in Huntington Beach, Blending Elevated Coffee, Matcha, Music, and Community
- Accountants Near Me Cheyenne Opens U.S. Directory for Accountants, Bookkeepers and Tax Services
- Sacred Surrogacy, CFC, and Egghelpers Launch Women's Retreats