AGC Biologics

AGC Biologics

End-to-end biopharma CDMO for gene therapies

Overview

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.

Significant Headcount Growth

About AGC Biologics

Simplify's Rating
Why AGC Biologics is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

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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Simplify's Take

What believers are saying

  • July 28, 2026 Yokohama won a multi-year deal worth hundreds of millions.
  • May 26, 2026 Teikoku chose AGC for rhMMP-7 microbial development and GMP manufacturing.
  • January 21, 2026 Autolus signed a ten-year lentiviral supply contract with minimum purchases.

What critics are saying

  • Colorado closures cut 267 jobs and signal shrinking U.S. biologics demand.
  • Yokohama starts in 2027; delayed commissioning keeps revenue stranded through 2026.
  • A prolonged CDMO downturn would force AGC Inc. to sell or shutter U.S. biologics assets.

What makes AGC Biologics unique

  • Three-continent microbial manufacturing lets AGC move projects between Seattle, Heidelberg, Chiba, and Copenhagen.
  • Yokohama adds mammalian, mRNA, and cell therapy capacity under one 2027 campus.
  • AGC's Japan footprint sells supply-chain resilience to regulators and customers after 2025 disruptions.

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Funding

Total Funding

$557.7M

Above

Industry Average

Funded Over

1 Rounds

Acquisition funding comparison data is currently unavailable. We're working to provide this information soon!
Acquisition Funding Comparison
Coming Soon

Benefits

Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

8%

1 year growth

8%

2 year growth

11%
Ochre Digi Media Pvt. Ltd.
Jul 29th, 2026
AGC Biologics lands commercial manufacturing agreement for Yokohama site worth hundreds of millions of dollars.

AGC Biologics lands commercial manufacturing agreement for Yokohama site worth hundreds of millions of dollars. Wednesday, July 29, 2026 Ahead of the official opening of AGC Biologics' Yokohama site, an international biopharmaceutical company has already secured half of the facility's mammalian manufacturing capacity with a multi-year commercial contract expected to reach hundreds of millions of dollars in total value. The Contract Development and Manufacturing Organization (CDMO) will leverage its new Yokohama facility to manufacture a minimum of 35 batches per year of five biopharmaceutical products for the undisclosed customer, securing a reliable global supply chain for patients worldwide. The agreement includes process transfer, scale-up, regulatory validation, and future commercial production. The customer will pursue multiple regulatory approvals with the EMA, FDA, MHRA, and PMDA. The aggressive manufacturing timeline includes four process performance qualifications (PPQ) campaigns in the first two years. Securing commercial production in Japan reflects a broader industry shift toward supply chain resilience, as global biopharmaceutical developers increasingly prioritize established, geopolitically stable manufacturing partners with locations that mitigate geopolitical, regulatory and trade risks. "AGC Biologics has the largest global network of single-use manufacturing capacity by volume outside of China, but that's not the full story," said Alberto Santagostino, President and CEO of AGC Biologics. "The market is demanding capable, reliable manufacturing partners with global quality standards and geographic flexibility. This agreement reflects the strength of our network, our single-use expertise, and the strategic role Japan can play in resilient biologics supply chains. Our newest Japan site in Yokohama synthesizes all our network learning in a location of increasing interest, and that carries the intrinsic cultural value of manufacturing quality and effective delivery." Once operational in 2027, the Yokohama site will deploy four 2,000-liter Cytiva single-use bioreactors and two 5,000-liter Thermo Fisher Scientific DynaDrive single-use bioreactors, adding 18,000 liters to AGC Biologics' existing capacity of single-use technology for biologics manufacturing. Select customers and guests are scheduled to be provided with the opportunity to visit the new site in December 2026, when construction is completed. "Securing a major commercial partner for Yokohama before the site is operational is a strong signal of confidence in what this facility will offer," said Tadashi Murano, President of AGC Life Science Company. "With the site located adjacent to the AGC Yokohama Technical Center, biopharmaceutical developers are understanding that choosing a CDMO with an established innovation ecosystem in Japan is a smart outsourcing strategy." The AGC Biologics' Yokohama site was part of the biomanufacturing investments made by Japan's Ministry of Economy, Trade and Industry in 2022. These strategic investments are designed to expand domestic production and reinforce Japan's position as a highly trusted, long-term biologics partner for life sciences industries within allied nations. Services available in Yokohama starting in 2027 will include: * Mammalian development and GMP manufacturing, with two downstream lines and flexible single-use bag capacity of 18,000 liters. * Cell therapy services with six clean rooms. * Messenger RNA (mRNA) development and manufacturing with 2 IVT, two purification lines, and two LNP lines. With existing cGMP manufacturing locations in the U.S., Japan, and Europe, AGC Biologics' track record will help kick off the manufacturing operation in Yokohama, utilizing the experience of: * More than three decades of GMP experience. * 100 successful regulatory inspections. * More than 30 commercial products launched, which received more than 100 separate regulatory agency approvals. * More than 400 products developed and manufactured for over 250 different customers. 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 Pharma Focus Asia work side-by-side with its clients and partners, to provide friendly and expert services. Pharma Focus Asia 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. Its 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 eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

The Mirror Democrat and Savanna Times-Journal
May 26th, 2026
AGC Biologics to manufacture Teikoku Seiyaku's rhmmp-7 drug substance.

AGC Biologics to manufacture Teikoku Seiyaku's rhmmp-7 drug substance. * 7 hrs ago HEIDELBERG, Germany and CHIBA, Japan, May 26, 2026 (GLOBE NEWSWIRE) - AGC Biologics, your friendly CDMO expert, was selected by Teikoku Seiyaku Co., Ltd., a leader in transdermal drug delivery, to provide microbial contract development and manufacturing services for KTP-001, a recombinant human matrix metalloproteinase-7 (rhMMP-7), to treat lumbar disc herniation. "Partnering with AGC Biologics was a clear choice. Their team has a proven track record in microbial manufacturing, and their global presence gives us the flexibility and security we need," said Dr. Hiroyuki Kubo, Director and Executive Officer at Teikoku Seiyaku. "We value their collaborative spirit and working together will be instrumental in bringing this important new therapy to patients." Development and GMP manufacturing for clinical trials Under the agreement, AGC Biologics will leverage its global network, with initial cell bank creation activities taking place at its Microbial Center of Excellence in Heidelberg, Germany. The project will then transition to the AGC Biologics' facility in Chiba, Japan, for process development and GMP manufacturing to support clinical trials. "Our role here in Heidelberg is to be a reliable and collaborative partner from the very beginning, applying our microbial development experience to build a robust foundation for this therapy," said Dieter Kramer, General Manager of the AGC Biologics Heidelberg site. "We have a 40-year-long tradition of helping projects advance and are well accustomed to partnering with other sites in our network to provide a steady journey towards GMP manufacturing." "We are delighted to support the Teikoku Seiyaku team on such an innovative project. It's a privilege to support their vision for a therapy that could offer a new, less invasive option for patients," said Susumu Zen-In, General Manager of the AGC Biologics Chiba site. A CDMO with a stable, global network This partnership highlights AGC Biologics' unique position as the only CDMO offering microbial manufacturing on three continents - Asia (Chiba, Japan), North America (Seattle, USA), and Europe (Heidelberg, Germany and Copenhagen, Denmark). This global network provides supply chain security and flexibility, allowing drug developers to de-risk their journey from clinical to commercial stages in a shifting geopolitical landscape. Frequently Asked Questions (FAQs): For a drug developer, why is a global manufacturing network important for supply chain security? A global network provides crucial flexibility and de-risks the supply chain by offering geopolitical stability and redundancy of supply. It allows for efficient tech transfer between sites with harmonized quality systems, offers multi-continent production options to meet regional market demands, and ensures business continuity. With facilities in the U.S., Europe, and Asia, AGC Biologics helps partners build a resilient manufacturing strategy that is not dependent on a single site or region. How is AGC Biologics investing to meet future microbial demand? AGC Biologics is committed to strategic growth that aligns with market needs. The company has brought a new microbial line online in the U.S. to support reshoring initiatives and is offering innovative capacity reservation models at its Heidelberg site in 10,000 L scale to provide long-term security for late-phase and commercial products. This is in addition to the extensive, established capabilities at its Copenhagen and Chiba sites, ensuring partners have access to robust, global capacity now and in the future. 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 Mycarrollcountynews work side-by-side with its clients and partners, to provide friendly and expert services. Mycarrollcountynews 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. Its 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 eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. About Teikoku Seiyaku Founded in 1848, Teikoku Seiyaku is dedicated to its mission "For a World Without Pain", leveraging its expertise in transdermal absorption technology. Teikoku Seiyaku develops, manufactures, and markets anti-inflammatory and analgesic patches, narcotic drugs for medical use, and other pharmaceutical products.

Associated Press
May 4th, 2026
Novelty Nobility partners with AGC Biologics to advance bispecific antibody candidate NN4101

Novelty Nobility, a clinical-stage South Korean biotech company, has expanded its manufacturing agreement with AGC Biologics to advance its bispecific antibody drug candidate NN4101 through process development and GMP manufacturing at AGC Biologics' Chiba, Japan facility. The collaboration follows successful cell line development completed in Copenhagen, Denmark. NN4101 is a first-in-class bispecific antibody targeting neovascular retinal diseases, combining a fully human anti-c-Kit monoclonal antibody with a VEGF trap. The partnership leverages AGC Biologics' global network across the US, Europe and Asia. AGC Biologics is expanding its Japanese operations with a new state-of-the-art facility in Yokohama, designed to offer large-scale GMP manufacturing using single-use bioreactor technology to meet growing regional and global demand.

ConnectWeb
May 4th, 2026
Novelty Nobility taps AGC Biologics to further develop bispecific drug candidate.

Novelty Nobility taps AGC Biologics to further develop bispecific drug candidate. AGC Biologics, Inc. Successful partnership continues as bispecific antibody candidate moves to GMP manufacturing; project highlights Japan's advanced capabilities in bioprocessing and AGC Biologics' expanding global network CHIBA, Japan, May 04, 2026 (GLOBE NEWSWIRE) - Novelty Nobility, a clinical-stage biotech company based in South Korea, expanded its manufacturing agreement with AGC Biologics, your friendly CDMO expert, to advance their bispecific antibody drug candidate through process development and GMP manufacturing at AGC Biologics' facility in Chiba, Japan. This second partnership, continued from the last year, underscores the successful track record and deep expertise AGC Biologics provides for developing complex biologics. The project leverages AGC Biologics' global network, having successfully completed cell line development in Copenhagen, Denmark. The program is now on track for a seamless tech transfer to the Chiba site for the next critical manufacturing stages. "AGC Biologics has proven to be an ideal manufacturing partner for advancing our most complex programs. Their seamless global network - from cell line development to GMP manufacturing - gives us the confidence to move NN4101 forward with speed and precision." said Sang Gyu Park, CEO of Novelty Nobility. "We believe this bispecific antibody has the potential to offer a truly differentiated treatment option for patients with neovascular retinal diseases." Novelty Nobility's bispecific antibody drug candidate NN4101 is a first-in-class bispecific antibody intended for the treatment of neovascular retinal diseases. It uniquely connects a fully human anti-c-Kit monoclonal antibody with a vascular endothelial growth factor (VEGF) trap. "Our continued partnership with Novelty Nobility is a testament to the trust and confidence customers have in our technical expertise and our global network's capabilities," said Tadashi Murano, President of the AGC Life Science Company. "Our mammalian expression teams are adept at handling complex proteins, and we are a world leader in applying flexible, single-use bioreactor technology. We are proud to support Novelty Nobility as they advance this innovative candidate toward the clinic." The project highlights the power of AGC Biologics' integrated global facility network, offering customers a seamless experience by combining world-class expertise with a strong regional presence. To further support growing demand in the region and globally, AGC Biologics is expanding its footprint in Japan with a new state-of-the-art facility in Yokohama. The Yokohama site is designed to utilize the latest single-use bioreactor technology to offer large-scale GMP manufacturing, making it one of the most advanced facilities of its kind in Japan. "When clients work with us, they tap into our entire global network which brings teams together for a seamless experience," noted Susumu Zen-in, Senior Vice President and General Manager of AGC Biologics' Chiba site. "This approach is creating wins for our partners and for AGC Biologics throughout the APAC region. The upcoming capacity at our new Yokohama site will only strengthen our ability to meet the global demand for vital biopharmaceuticals." 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 Connectweb work side-by-side with its clients and partners, to provide friendly and expert services. Connectweb 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. Its 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 eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. About Novelty Nobility Novelty Nobility is a clinical-stage biotech company driven by a mission to maximize the potential of therapeutic antibodies. The company is dedicated to developing next-generation treatments for immunology and inflammatory diseases. Leveraging its proprietary fully human antibody discovery platform, PREXISE(R)-D, together with deep expertise in protein engineering, Novelty Nobility is advancing a diverse pipeline of monoclonal antibodies (mAb), bispecific antibodies (bsAb), and antibody-drug conjugates (ADC) - modalities where scientific novelty translates into meaningful benefits for patients.

StockTitan
Jan 26th, 2026
Autolus (NASDAQ: AUTL) signs 10-year AGC Biologics lentiviral supply pact

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.

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