WA-AGC-BIOLOGICS
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.”
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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230124005438/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
A-CAP Announces Successful Divestiture of Standard de Liège SA and Immobilière du Standard de Liège SRL6.6.2025 22:32:00 CEST | Press release
Successful Transaction Marks Another Milestone in A-CAP’s Soccer Club Portfolio Strategy Advantage Capital Holdings, LLC (“A-CAP” or “The Company”), a New York-based insurance and financial services company with over $12 billion in assets, today announced the successful divestiture of Standard de Liège SA (“Standard Liège” or the “Club”), one of Belgium's most historic soccer clubs, and Immobilière du Standard de Liège SRL, the corporate entity that owns the Club's stadium, Maurice Dufrasne Stadium, to a consortium of buyers led by Standard Liège Chief Executive Officer Giacomo Angelini. This transaction marks the end of 777 Partners’ legacy involvement with the Club and sets the stage for the Club’s future growth and success, both on and off the field. Benefits of the transaction include: Increased stability across the Club’s shareholder base, which clears the path for future investments, Operational clarity, establishing a unified direction that will allow both players and management
Populous Acquires Fentress Architects, Expanding Global Aviation Portfolio6.6.2025 20:00:00 CEST | Press release
Populous, the world-renowned design firm specializing in sport and entertainment venues, today announced the acquisition of Denver-based Fentress Architects, a global leader in iconic aviation projects and prominent public buildings, including convention centers, museums and government facilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250606849000/en/ Los Angeles International Airport. Designed by Fentress Architects. This strategic acquisition unites two of the most respected names in architecture, combining Populous’ unparalleled expertise in designing memorable experiences with Fentress’ award-winning portfolio of aviation, civic and cultural landmarks. The acquisition significantly broadens the scope and scale of services that Populous can offer clients across the globe. Bruce Miller, Populous Global Chair and CEO, commented: “We are committed to expanding the breadth of our practice. Fentress Architects has lon
Vertex Presents New Data on Benefits of ALYFTREK® and Importance of Achieving Lower Sweat Chloride Levels at the European Cystic Fibrosis Conference6.6.2025 18:00:00 CEST | Press release
- Oral presentation on outcomes following treatment with CFTR modulators show that improvements in CFTR function, as measured by lower sweat chloride, correlate with better outcomes for people with cystic fibrosis - - Oral presentation on new post hoc data from randomized, controlled and open-label trials suggest improved quality of life results with ALYFTREK compared to TRIKAFTA® – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data across multiple studies demonstrating positive clinical and quality of life benefits of treatment with CFTR modulators and, in particular, ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor), which is approved in the United States and United Kingdom and is currently under review with health authorities in the EU, Canada, Australia, New Zealand and Switzerland. These data were presented at this year’s European Cystic Fibrosis Society’s (ECFS) 48th European Cystic Fibrosis Conference held June 4-7, 2025, in Milan, Italy. During the conferenc
Andersen Consulting tilføjer dimension med David and Golyat6.6.2025 16:33:00 CEST | Pressemeddelelse
Andersen Consulting udbygger sin globale konsulentkapacitet gennem en samarbejdsaftale med David and Golyat, en filippinsk konsulentvirksomhed inden for digital strategi. Med et stærkt fokus på business intelligence, kundeindsigt og digital first-eksekvering arbejder David and Golyat med kunder på tværs af flere sektorer – herunder regeringer, udviklingsorganisationer og private virksomheder – for at skabe langsigtet værdi gennem datainformerede beslutninger. Miko David, administrerende partner i David and Golyat, siger: "Vi ser frem til samarbejdet med Andersen Consulting, da det er en milepæl i vores vækstforløb. Ved at kombinere vores ekspertise inden for digital strategi og Andersen Consultings globale platform er vi i stand til at levere endnu større værdi til kunder, der navigerer på komplekse markeder." "Dette samarbejde betyder, at vi kan tilføre en ekstra dimension til vores globale konsulentplatform," siger Mark L. Vorsatz, global bestyrelsesformand og administrerende direktø
IBSA Derma at IMCAS Asia 2025: spotlight on the future of aesthetic medicine in the 10th Anniversary Year of NAHYCO® Technology6.6.2025 16:00:00 CEST | Press release
IBSA Derma, the dermoaesthetic division of Swiss company IBSA, will participate in the 18th IMCAS Asia Congress in Bangkok, gathering over 3,000 professionals from across the region to explore the future of aesthetic and regenerative medicine.With the presence in the Congress and a dedicated scientific symposium, the company reaffirms its commitment to advancing bioremodeling approaches and promoting a holistic, science-driven vision of authentic beauty.This year marks a key milestone for IBSA Derma: 10 years of NAHYCO® Technology, a patented innovation in hyaluronic acid science that continues to shape the future of tissue regeneration. IBSA Derma – the dermoaesthetic division of IBSA – once again confirms its leadership in the international aesthetic medicine landscape by participating in the 18th edition of IMCAS Asia, taking place from June 6 to 8 in Bangkok, Thailand. With over 3,000 attendees expected, the event represents a key opportunity for physicians and experts to share the
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom