Trending...
- The Paris Court of International Arbitration Elects Dr. John J. Maalouf as its New President
- Ditch Micromanagement: New Leadership Book for Results-Driven, Accountability-Based Teams
- ImagineX, in Collaboration with Qualys, Launches New mROC Services to Transform Enterprise Cyber Risk Management
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
- SlotCycle Joins Association of Gaming Equipment Manufacturers (AGEM) to Advance Sustainable Gaming Solutions
- RWA Infra Development L.L.C. announces the $RWAID token. "$RWAID tokenizing infrastructure for the masses."
- Mental Health Awareness Month—Tennessee Enacts Psychotropic Testing Law
- Be Prepared for the Qualitative and Quantitative Effects of Tariffs: How Businesses Can Navigate Potential Disruption in Finances and Production
- Bold Beauty Project UCLA Edition Photography Exhibition on May 18
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
- Genuine Hospitality, LLC Selected to Operate Claridge House Chicago Gold Coast
- Lamar Odom Issues Public Challenge to X Platform Over Censorship of His Anti-Addiction Crypto Campaign
- PBK Miner completes $80 million Series B financing to support AI cloud mining and increase user investment return by 25%
- Asset-Backed Green Crypto: Fueling the Trillion-Dollar Revolution
- Spokane: Traffic Impacts Starting Week of May 12th
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
Filed Under: Business
0 Comments
Latest on Washingtoner
- Spokane: Flags Lowered for Justice Owens
- Managing Summer Staffing Surges with Confidence: Why Name Badges Are a Must for Seasonal Success
- Visa Named Title Sponsor of Ascending Athletes' Business Owners Summits for NFL Entrepreneurs
- Space Resources Company Interlune Unveils Full-Scale Prototype of Excavator for Harvesting Helium-3 from the Moon
- The Paris Court of International Arbitration Elects Dr. John J. Maalouf as its New President
- $56.7 Million Announced in Q1 2025 with Revenue Growth and Progress Toward NASDAQ Uplisting for AI Marketing Company: IQSTEL, Inc. Stock Symbol: IQSTD
- SAVVY MINING raised $500 million and launched BTC.XRP.DOGE cloud mining, increasing investors' returns by 30%
- New National Nonprofit Launches to Capture Firsthand Accounts of Adoption Stories
- The Tide Project Opens at Biennale Architettura 2025 in Venice Amplifying Youth Voices
- Wall Street analysts say BTC.XRP.DOGE cloud mining company SIX MINING is expected to achieve a 5-fold increase, allowing users to easily mine BTC
- Gen X Takes The Reins: New Book Guides Caregivers Juggling Parents, Kids, And Grandkids With Humor And Heart
- Fray Fitness Launches Memorial Day Sale and Veteran Organization Giveaway
- ABM for Good™ Launches First Project with Build Change
- Lucky Envelope Brewing hosts My Name Story Exhibit by Judy Lee
- ImagineX, in Collaboration with Qualys, Launches New mROC Services to Transform Enterprise Cyber Risk Management
- Ditch Micromanagement: New Leadership Book for Results-Driven, Accountability-Based Teams
- Jay Tapp was named Managing Director in British Columbia
- Hubei Heavy Equipment Makes a Striking Appearance at CIMT and Competes with International Brands
- 20 Patents Issued Worldwide, Cementing Company Leadership. First Ever Cable-Free 12-Lead ECG: HeartBeam, Inc. (Stock Symbol: BEAT)
- NASDAQ Uplisting for Higher Market Exposure and Wide Corporate Benefits to AI Boosted Marketing Company On Track Towards $1 Billion Revenue by 2027