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AGC Biologics is a global CDMO that provides end-to-end development and manufacturing for biopharmaceuticals, including therapeutic proteins, plasmid DNA, viral vectors, and cell therapies. It moves projects from early development to full-scale production and offers fast-track options for orphan drugs, backed by cGMP facilities across the US, Europe, and Asia, plus a new Longmont, Colorado site for cell and gene therapy. The company differentiates itself through its international footprint, strict regulatory quality adherence, and ability to accelerate complex therapies. Its goal is to help biopharma partners bring new treatments to market quickly and safely via integrated development and manufacturing solutions.
Industries
Industrial & Manufacturing
Biotechnology
Healthcare
Company Size
1,001-5,000
Company Stage
Acquired
Total Funding
$557.7M
Headquarters
Bothell, Washington
Founded
2001
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Total Funding
$557.7M
Above
Industry Average
Funded Over
1 Rounds
Autolus (NASDAQ: AUTL) signs 10-year AGC Biologics lentiviral supply pact. Rhea-AI filing summary. Autolus Therapeutics plc filed a prospectus supplement covering the resale by selling securityholders of up to 54,584,250 American Depositary Shares (ADSs), including 3,265,306 ADSs issuable upon exercise of outstanding warrants. The ADSs trade on Nasdaq under the symbol AUTL, and the closing price on January 23, 2026 was $1.46 per ADS. The supplement also incorporates an 8-K describing a new 10-year Master Supply Agreement between Autolus Limited and AGC Biologics S.p.A for lentiviral vector, a critical raw material for the company's CAR-T products, including AUCATZYL and clinical trial products. Autolus Limited committed to purchase a minimum of 14 batches of lentiviral vector in the first two calendar years and a minimum value of EUR 25 million of products and services over the subsequent five-year period, under a non-exclusive arrangement that gives AGC a first right to negotiate new manufacturing activities for the obe-cel product. Insights. Autolus locks in long-term viral vector supply with minimum purchase commitments. Autolus Limited, a wholly owned subsidiary of Autolus Therapeutics, entered a 10-year Master Supply Agreement with AGC Biologics S.p.A for lentiviral vector, which is described as critical for manufacturing the company's CAR-T products, including AUCATZYL and clinical trial materials. The pact is non-exclusive but establishes the general terms for products and services via individual work orders. The company has committed to buy a minimum of 14 batches of lentiviral vector in the first two calendar years and at least EUR 25 million of products and services over the following five-year period. These minimums help secure supply continuity but also create multi-year purchase obligations whose scale, relative to Autolus's overall spending, is not detailed in the excerpt. The agreement runs for ten years and can be terminated for default by either party or by the company on notice subject to certain fees, while AGC receives a first right to negotiate new manufacturing activities for the obe-cel product. Future filings, such as the Form 10-Q for the quarter ending March 31, 2026, may provide the filed agreement text and more granular financial impact. Faq. The prospectus supplement relates to the resale from time to time by selling securityholders of up to 54,584,250 American Depositary Shares (ADSs), representing the same number of ordinary shares. This includes 51,318,944 ADSs representing existing ordinary shares and up to 3,265,306 ADSs issuable upon exercise of outstanding warrants. Is Autolus Therapeutics itself selling ADSs in this AUTL filing? The document states that the Prospectus and this supplement relate to the resale of ADSs by identified selling securityholders. It does not describe Autolus Therapeutics plc as the seller of these securities, focusing instead on holders who may sell from time to time under the registration. What new agreement did Autolus disclose with AGC Biologics in this filing? Autolus Limited entered into a Master Supply Agreement with AGC Biologics S.p.A on January 21, 2026 for the manufacture and supply of lentiviral vector. The agreement sets out terms under which AGC will provide products and services to support Autolus's CAR-T manufacturing operations. How long is the AGC Biologics supply agreement with Autolus and can it be terminated? The Master Supply Agreement runs for a fixed term of ten years. It may be terminated by either party for default, and it may be terminated by the company upon written notice, in which case the company must pay certain fees as specified in the agreement. What minimum purchase commitments does Autolus have under the AGC Master Supply Agreement? Under the agreement and initial statement of work, Autolus Limited committed to purchase a minimum of 14 batches of lentiviral vector during the first two calendar years of the term and to purchase a minimum value of EUR 25 million of products and services during the subsequent five-year period. Why is the AGC lentiviral vector supply important for Autolus Therapeutics (AUTL)? The filing describes lentiviral vector supplied by AGC as a critical raw material for manufacturing the company's CAR-T products. Autolus Limited is noted as the sole manufacturer of all CAR-T products supplied by Autolus's operational companies globally, including commercial AUCATZYL and clinical trial products. What special rights does AGC Biologics receive regarding Autolus's obe-cel product? The agreement gives AGC Biologics the first right to negotiate with Autolus Limited for new manufacturing activities related to the company's obecabtagene autoleucel (obe-cel) product, as described in the filing.
AGC Biologics and Repair Biotechnologies partner on novel mRNA therapeutic to combat the leading cause of human mortality. AGC Biologics today announced it is partnering with Repair Biotechnologies to tackle one of the world's most persistent health challenges and cause of mortality. The collaboration will focus on developing and manufacturing a novel mRNA therapy to rapidly stabilize and reduce the size of atherosclerotic plaques in major blood vessels. Rupture of unstable plaque and subsequent heart attack or stroke is the leading cause of death, accounting for 27% of all human mortality. "Developing a novel mRNA therapeutic as a part of the vital goal of curing atherosclerotic cardiovascular disease is a complex task, and robust manufacturing is critical to our progress," said Reason, CEO and co-founder, Repair Biotechnologies. "We chose AGC Biologics because they have mastered the entire production chain for therapeutics of this class, eliminating critical risks and delays to provide a fast and reliable path to the GMP drug product needed for our clinical trials. We are pleased to work with AGC Biologics to advance our mission to help people enjoy longer, healthier lives." For pioneering companies like Repair Biotechnologies, navigating the complex manufacturing landscape is a critical challenge. By consolidating the entire production journey, AGC Biologics provides a streamlined and de-risked path to the clinic and market without expensive services or complex technologies. This collaboration will leverage AGC Biologics' comprehensive mRNA manufacturing knowledge and expertise that allows innovators to manage the entire process from the initial plasmid DNA blueprint to the final drug product encapsulated in lipid nanoparticles with a single, experienced partner. "For clients like Repair Biotechnologies, we can be the most cost-effective, reliable, cGMP provider that can take life-saving mRNA treatments through the journey from preclinical to commercial stages," said Alberto Santagostino, CEO, AGC Biologics. "As the friendly CDMO expert, this is emblematic of our no-frills, expert approach is economical while never compromising good manufacturing and quality. Our approach ensures developers can radically transform quality of life around the world without breaking the bank." This partnership is a noteworthy addition to the present evolution of mRNA technology, moving beyond infectious diseases and into the realm of treating chronic, age-related conditions. In 2021 the AGC Biologics Heidelberg facility provided plasmid DNA starting material for the Pfizer-BioNTech COVID-19 vaccine. Building on mRNA advances from the pandemic, Repair Biotechnologies is developing a new therapy that breaks down toxic excess free cholesterol inside cells. This process aims to reverse previously irreversible cardiovascular conditions by removing a key detriment to aging, obesity, and cardiovascular caused death. The plasmid DNA and messenger RNA production line at the AGC Biologics Heidelberg site uses state-of-the-art single-use equipment, creating flexibility, shorter timelines and faster project turnover. The site's GMP practices are compliant with European Medicines Agency and U.S. Food and Drug Administration standards. To learn more about AGC Biologics' end-to-end mRNA services, visit www.agcbio.com/capabilities/mrna. About Repair Biotechnologies Repair Biotechnologies develops first-in-class therapies that break down the undruggable target of toxic free cholesterol inside cells to rapidly reduce arterial plaque in atherosclerosis and familial hypercholesterolemia, reverse liver fibrosis in metabolic disorders, and which have the potential to treat numerous other conditions associated with aging and obesity. 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, to provide friendly and expert services. We provide world-class development and manufacturing 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 locations in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. View source version on businesswire.com:https://www.businesswire.com/news/home/20251119073857/en/ AGC Biologics media contact:[email protected]
AGC Biologics, Repair Biotechnologies partner to develop & manufacture mRNA therapeutic. The collaboration will leverage AGC Biologics' mRNA manufacturing knowledge and expertise to combat a leading cause of human mortality. AGC Biologics is partnering with Repair Biotechnologies to develop and manufacture a novel mRNA therapy to rapidly stabilize and reduce the size of atherosclerotic plaques in major blood vessels. Rupture of unstable plaque and subsequent heart attack or stroke is the leading cause of death, accounting for 27% of all human mortality. "Developing a novel mRNA therapeutic as a part of the vital goal of curing atherosclerotic cardiovascular disease is a complex task, and robust manufacturing is critical to our progress," said Reason, CEO and co-founder, Repair Biotechnologies. "We chose AGC Biologics because they have mastered the entire production chain for therapeutics of this class, eliminating critical risks and delays to provide a fast and reliable path to the GMP drug product needed for our clinical trials. We are pleased to work with AGC Biologics to advance our mission to help people enjoy longer, healthier lives." For Repair Biotechnologies, navigating the complex manufacturing landscape is a critical challenge. By consolidating the entire production journey, AGC Biologics provides a streamlined and de-risked path to the clinic and market without expensive services or complex technologies. This collaboration will leverage AGC Biologics' mRNA manufacturing knowledge and expertise that allows innovators to manage the entire process from the initial plasmid DNA blueprint to the final drug product encapsulated in lipid nanoparticles with a single, experienced partner. "For clients like Repair Biotechnologies, we can be the most cost-effective, reliable, cGMP provider that can take life-saving mRNA treatments through the journey from preclinical to commercial stages," said Alberto Santagostino, CEO, AGC Biologics. "As the friendly CDMO expert, this is emblematic of our no-frills, expert approach is economical while never compromising good manufacturing and quality. Our approach ensures developers can radically transform quality of life around the world without breaking the bank."
DNA Cancer Vaccine Market size Clinical Trials FDA approval Market Opportunity Insight. First DNA Cancer Vaccine Commercial Approval Expected By 2030 says kuick Research. Delhi, Oct. 16, 2025 (GLOBE NEWSWIRE) - Global DNA Cancer Vaccine Clinical Trials, Development Technology Platforms & Market Opportunity Outlook 2026 Report Findings & Highlights: * First DNA Cancer Vaccine Commercial Approval Expected By 2030 * DNA Cancer Vaccines In Clinical Trials: > 20 Vaccines * Global DNA Cancer Vaccines Clinical Trial Insight By Company, Indication & Phase * Insight On DNA Cancer Vaccine Development Technology Platforms: >10 Platforms * Comparison With Other Cancer Immunotherapies * DNA Cancer Vaccines Recent Innovations * Competitive Landscape In the rapidly evolving landscape of cancer therapy, DNA vaccines are rapidly emerging as a focal point for novel immunotherapeutic approaches. Through their administration of plasmid DNA coding for tumor-specific antigens, they activate the immune system of the body to recognize and eliminate cancer cells. Previously viewed as an out of the mainstream strategy because of delivery and immunogenicity issues, DNA cancer vaccines are now entering an era of fast paced development driven by breakthroughs in molecular biology, delivery systems, and individualized medicine. One of the most compelling features of DNA vaccines is that they can be designed and applied flexibly. For instance, Inovio Pharmaceuticals' bizalimogene ralaplasmid acts against HPV-associated cervical cancer by encoding viral oncogenes E6 and E7, which are principal contributors to tumor growth. Administered through electroporation, this vaccine has been shown to induce strong cytotoxic T-cell immune responses, representing a major step forward for precision immunotherapy. Other companies, meanwhile, are proceeding along different lines. IMUNON's IMNN-001, an ovarian cancer vaccine targeting advanced disease, utilizes a nanoparticle-based IL-12 plasmid that targets the tumor microenvironment and increases immune response with the addition of chemotherapy. Outcomes from current trials are anxiously anticipated, as preliminary studies showed increased survival. The range of delivery vehicles also reflects the growing maturity of DNA vaccine technology. While electroporation is a much used technique for improving vaccine delivery, new technologies are on the horizon. NEC Bio Therapeutics has collaborated with AGC Biologics to create NECVAX-NEO1, an orally administered DNA vaccine based on bacteria to carry plasmid DNA encoding patient-specific tumor neoantigens. This novel technology relies on artificial intelligence for design and has the potential to greatly simplify large-scale production and individualized cancer vaccines. In addition to therapeutic measures, prevention is also in the works. Researchers at the University of Oxford and Francis Crick Institute are developing LungVax, a preventive DNA vaccine for high risk lung cancer patients. This project marks a trend toward moving cancer immunization strategies from treatment to early interception, as supported by Cancer Research UK. Carrying the most prevalent neoantigens of early lung tumors, LungVax looks to train the immune system to recognize and kill cancer cells before they spread. Platform innovation is a second force pushing the wave of DNA vaccine development. IMUNON's PlaCCine(R) system, initially developed for COVID-19, is now a platform for multi-antigen cancer vaccines. Its synthetic, non-viral delivery system has stability and immune stimulation benefits over mRNA vaccines, expanding new horizons in oncology. In the same vein, DNA origami platforms like DoriVac created by the Wyss Institute leverage nanoscale accuracy to arrange immune-stimulatory molecules at a much greater efficiency level, greatly enhancing the effectiveness of immune responses. Such engineering facilitates very tailored and modular vaccine design on a higher level. Biomarker science and immunomonitoring advances are also having a significant impact. Since patient reactions to immunotherapy continue to be unpredictable, data-driven strategies are being employed in order to customize treatments. From genomics through proteomics, technologies enable scientists to discover biomarkers that indicate whether a patient is likely to react, to minimize risk and maximize effectiveness. CRISPR gene editing has further broadened the utility of DNA cancer vaccines. By editing genes to increase antigen expression or control immune activation, CRISPR allows for the construction of vaccines not only more targeted but also safer. These advances are imperative as DNA vaccines progress from experimental trials to potential approval and universal use. Cross-industry cooperation continues to support the space. PharmaJet's needle-free delivery system Tropis(R) is already being employed by Immuno Cure for HIV vaccines, but the potential broadens to cancer. The emphasis on enhancing comfort and immune activation by means of skin delivery platforms is part of a broader trend toward making DNA vaccination a patient-friendly, scalable reality. With rising investment, clinical success, and technological innovation, DNA cancer vaccines are transforming from experimental reagents to legitimate contenders in the mainstream practice of oncology. Their potential is in their flexibility, their ability to be personalized, and their compatibility with established and emerging therapies.
AGC Biologics will permanently lay off 218 employees in Boulder, 48 in Longmont and one in K..
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Industries
Industrial & Manufacturing
Biotechnology
Healthcare
Company Size
1,001-5,000
Company Stage
Acquired
Total Funding
$557.7M
Headquarters
Bothell, Washington
Founded
2001
Find jobs on Simplify and start your career today