AGC Biologics

What AGC Biologics does

AGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) providing end-to-end development, GMP manufacturing, and commercialization services for protein-based biologics and advanced therapies. The company operates seven cGMP facilities across the United States (Seattle, Boulder, Longmont), Europe (Copenhagen, Heidelberg, Milan), and Asia (Chiba, Yokohama), with a 622,000 sq ft Longmont campus and a new 20,000 m² Yokohama facility under construction. Its service portfolio spans mammalian biologics (using the proprietary FDA/EMA-approved CHEF1 Expression System), microbial fermentation (Heidelberg's 40-year tradition), cell therapy (autologous and allogeneic), viral vector manufacturing (proprietary BravoAAV and ProntoLVV platforms), plasmid DNA, and mRNA, supporting 250+ customers and 30+ commercial product approvals across 100+ regulatory inspections.

The company's core technology stack centers on single-use bioreactor-based manufacturing with a proprietary scale-out architecture (6Pack System) that uses 2,000L bioreactors as modular building blocks scalable to 12,000L, reducing capital risk versus traditional stainless-steel scale-up. Differentiated programs include AGCellerate (1.0 KG mAb GMP material in 11 months at fixed price) and CMC Jumpstart (pre-GMP viral vector assessment). Business operations are organized around specialized Centers of Excellence by modality, including Cell and Gene Therapy at Milan/Longmont, microbial at Heidelberg, mammalian at Copenhagen/Seattle, and a dedicated Cell and Gene Business Division.

AGC Biologics is a private wholly-owned subsidiary of AGC Inc. (a Japanese conglomerate operating under AGC Life Science Company) and generates revenue through fee-for-service CDMO contracts with project-based pricing, including capacity reservation models (Heidelberg 10,000L microbial) and fixed-cost/fixed-timeline programs (AGCellerate). Its go-to-market combines direct enterprise sales through regional business development teams in the US, Europe, and Asia with major industry event participation (BIO International Convention, ISCT, Interphex Week Tokyo). Customers range from early-stage biotech startups to large pharmaceutical companies across multiple modalities, with notable enterprise relationships including BioNTech (pDNA supply for COVID-19 vaccines), Adaptimmune (CAR-T lentiviral vectors), and Autolus Therapeutics (CAR-T lentiviral vectors for AUCATZYL).

Name

AGC Biologics

Legal name

AGC Biologics Inc.

Website

https://agcbio.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

AGC Biologics is a global CDMO providing end-to-end development and GMP manufacturing for mammalian biologics, microbial, cell therapy, viral vector, pDNA, and mRNA products across 7 facilities in the US, Europe, and Asia. It serves 250+ biopharma and biotech customers with proprietary platforms including CHEF1, BravoAAV, ProntoLVV, and AGCellerate.

Ownership category

akta.pro rank

Product category

Biopharmaceutical CDMO Services

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834)

akta.pro primary industry

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

akta.pro secondary industries

Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE), mRNA/LNP & Nucleic Acid Therapeutics CDMO (HLAGABAF), mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), Gene Therapy Vector Manufacturing & CDMO Services (HLAAACAJ), Biologic API/Drug Substance Manufacturing Services (HLAAAKAA), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

Keywords

• Biologics contract manufacturing
• Cell and gene therapy CDMO
• Mammalian cell culture services
• Microbial fermentation manufacturing
• Viral vector production

Headquarters

HQ city

Bothell

HQ country

United States

HQ region

North America

Offices6 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Infrastructure, Operations, Technology or R&D, Supply Chain

Revenue model

1. Contract Development and Manufacturing (CDMO) Services: AGC Biologics generates revenue through fee-for-service contracts for development and manufacturing of biologics across mammalian, microbial, cell therapy, viral vector, plasmid DNA, and mRNA platforms. Revenue is earned through project-based engagements spanning pre-clinical through commercial phases, including process development, GMP manufacturing, fill-finish, and quality/regulatory services. Services are priced per project with models including guaranteed timelines and fixed costs (AGCellerate) and capacity reservation models.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels9 records

Core offering

AGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) providing fee-for-service development and manufacturing of protein-based biologics and advanced therapies. The company offers mammalian biologics, microbial fermentation, cell therapy, viral vector (AAV, LVV, RVV), plasmid DNA, and messenger RNA manufacturing from pre-clinical through commercial stages, leveraging proprietary platforms (CHEF1, BravoAAV, ProntoLVV, AGCellerate) and a tri-continental cGMP facility network spanning the U.S., Europe, and Asia.

Product overview

AGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) providing development and manufacturing services for protein-based biologics and advanced therapies. The company operates a multi-site global network spanning the US, Europe, and Asia with facilities in Seattle, Copenhagen, Heidelberg, Milan, Chiba, and Yokohama. Their core offerings include mammalian biologics services (using proprietary CHEF1™ Expression System), microbial biologics services, cell therapy services (autologous and allogeneic), viral vector services (AAV, LVV, RVV), plasmid DNA, and messenger RNA manufacturing. Specialized proprietary platforms include BravoAAV™ for adeno-associated vectors, ProntoLVV™ for lentiviral vectors, AGCellerate™ for guaranteed timelines and fixed-cost monoclonal antibody production, CMC Jumpstart™ for viral vector CMC assessment, and the Proveo™ ADC partnership program. End-to-end services encompass tech transfer, process development, cell line development, analytical and formulation development, process validation, cGMP manufacturing, quality systems management, and fill-finish services. The company leverages single-use bioreactor technology and scale-out manufacturing strategies to offer flexible, scalable solutions for clinical and commercial production.

Differentiator

Problem solved

Functional benefit

Brands

• AGCellerate: Guaranteed timeline, fixed cost program offering GMP material in rapid timelines for monoclonal antibodies and viral vectors.
• BravoAAV
• ProntoLVV
• Proveo
• CMC Jumpstart

Products and services

• Mammalian Biologics Services Development and manufacturing services for protein-based biologics using mammalian cell lines, from pre-clinical through commercial production, with flexible single-use manufacturing scales. For biopharmaceutical companies developing monoclonal antibodies, fusion proteins, and biosimilars.
• Microbial Biologics Services Microbial expression services using E. coli, Pichia pastoris, and other systems for antibody fragments, growth factors, enzymes, and other proteins, from development through commercial scale. Center of Excellence at Heidelberg supports 10,000L capacity reservation for late-phase and commercial products.
• Cell Therapy Services Global cell therapy services supporting all stages from pre-clinical through commercialization, working with hMSCs, exosomes, CD34+, T-cells, NK-cells, using autologous and allogeneic methods. Milan site is the first GMP facility approved in Europe for ex-vivo gene therapy manufacturing.
• Viral Vector Services Viral vector manufacturing for gene therapies including adeno-associated viral vectors (AAV), lentiviral vectors (LVV), and retroviral vectors (RVV) using proprietary BravoAAV and ProntoLVV platforms. For cell and gene therapy developers.
• Plasmid DNA (pDNA) Manufacturing Non-GMP and GMP supply of plasmid DNA materials supporting vaccine creation, RNA drugs, gene therapy, and viral vector starting materials. Heidelberg serves as the European Center of Excellence for pDNA production.
• Messenger RNA (mRNA) Manufacturing mRNA manufacturing in R&D and GMP grades for vaccines and therapeutics, with customized process development services and extensive in-house analytical methods. Supplied pDNA starting material for Pfizer-BioNTech COVID-19 vaccine.
• BravoAAV Platform Templated adeno-associated viral vector platform for pre-clinical through commercial AAV production with adherent and suspension processes. Includes prequalified scale-down models, in-network pDNA supply, and comprehensive analytical methods.
• ProntoLVV Platform Pre-qualified end-to-end lentiviral vector platform enabling GMP production in half the time of conventional methods, with in-network plasmid DNA supplies and comprehensive analytical methods. Guarantees at least 1e11 TU of LVV material in nine months.
• AGCellerate Program Guaranteed timeline, fixed cost, and guaranteed product quantity program for monoclonal antibodies (1.0 KG in 11 months) and lentiviral vectors, backed by CHEF1 Expression System with FDA and EMA approved cell line. Similar fixed-quantity programs for AAV and pDNA.
• CMC Jumpstart Program CMC peace-of-mind program providing pre-GMP assessment for viral vector developers before committing to GMP production, allowing assessment of vector viability.
• Proveo ADC Program End-to-end antibody-drug conjugate solution through partnership with multiple industry leaders, streamlining ADC development and manufacturing.
• cGMP Manufacturing Manufacturing scales and services from pre-clinical through full-scale commercialization using single-use bioreactor technology, growing with project needs across mammalian, microbial, cell therapy, viral vector, and mRNA modalities.
• Fill & Finish Services Suite of fill/finish services for protein-based drug products and advanced therapies through partnership with BioConnection for aseptic fill-finish, providing seamless gene-to-vial services under single contract.

Quantifiable outcome

• Guaranteed delivery of 1.0 KG of monoclonal antibody GMP material in 11 months through AGCellerate program
• +6 more outcomes

Named customers29 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature8 records

Partnerships

21 partnerships are on record, tiered core and strategic.

• Teikoku Seiyaku Co., Ltd.coreStrategic or Co-development Partner · 26 May 2026AGC Biologics selected to provide microbial contract development and manufacturing for KTP-001 (recombinant human MMP-7) targeting lumbar disc herniation. Initial cell bank at Heidelberg site transitions to Chiba site for process development and GMP manufacturing to support clinical trials.
• Orphan Therapeutics Accelerator (OTXL)coreStrategic or Co-development Partner · 11 May 2026AGC Biologics joined OTXL's Clinical Development Network as manufacturing partner to enhance development and commercialization of cell and gene therapies for ultra-rare conditions.
• Novelty NobilitycoreStrategic or Co-development Partner · 4 May 2026Expanded manufacturing agreement for bispecific antibody NN4101 (first-in-class anti-c-Kit mAb + VEGF trap for neovascular retinal diseases). Cell line development in Copenhagen; process development and GMP manufacturing in Chiba. Second partnership following successful initial collaboration.
• Fondazione TelethoncoreStrategic or Co-development Partner · 19 January 2026Milan facility manufactured Waskyra (ex vivo gene therapy for Wiskott-Aldrich syndrome) with simultaneous FDA and European Commission marketing authorization. AGC Biologics provided lentiviral vector production, patient-specific cell manufacturing, and regulatory compliance from preclinical through commercial.
• AsimovstrategicTechnology or Integration · 12 January 2026Partnership to provide cost-effective, simplified, and secure manufacturing approach for viral vector production, combining Asimov's computational biology tools with AGC Biologics' manufacturing capabilities.
• ATUMcoreTechnology or Integration · 2 December 2025Partnership expanded AGC Biologics' Cell Line Development Center of Excellence by integrating ATUM's Leap-In Transposase platform, shortening development timelines and increasing yields for complex bi and trispecific proteins.
• AAVantgardecoreStrategic or Co-development Partner · 21 November 2025Manufacturing agreement to produce dual-vector gene therapies for inherited retinal diseases (Stargardt disease and Usher syndrome-related retinitis pigmentosa) using BravoAAV platform, supporting clinical development in U.S., UK, and Europe.
• Repair BiotechnologiescoreStrategic or Co-development Partner · 19 November 2025Partnership to develop novel mRNA therapeutic targeting atherosclerotic plaques, addressing the leading cause of human mortality. AGC Biologics provides manufacturing capabilities to support development and clinical trials.
• Rarity PBCcoreStrategic or Co-development Partner · 23 October 2025Partnership to provide manufacturing services for RDP-101 gene therapy candidate targeting ADA-SCID (Bubble Baby Disease). Includes process development, GMP manufacturing, and validation toward FDA approval.
• NEC Bio TherapeuticscoreStrategic or Co-development Partner · 7 August 2025Collaboration to manufacture personalized cancer vaccines leveraging AGC Biologics' GMP capabilities and global network.
• Quell TherapeuticsstrategicStrategic or Co-development PartnerCDMO alliance for T-Regulatory cell therapies for immune disorders, supporting IND submission preparedness.
• Pandorum TechnologiesstrategicStrategic or Co-development PartnerPartnership for exosome-based regenerative therapies (Kuragenx) with FDA Orphan Drug Designation for ocular surface diseases. AGC Biologics provides US and European manufacturing for global clinical development.
• Nucelion Therapeutics (Bharat Biotech subsidiary)strategicChannel Partner/ Reseller/ DistributorAsia-Pacific distribution partnership for Pandorum Technologies' exosome-based therapies through Nucelion's network.
• RoosterBiostrategicStrategic or Co-development PartnerStrategic partnership creating end-to-end solution for hMSC and exosome therapy development and production. Combines RoosterBio's cell/media products and process development with AGC Biologics' global CGT manufacturing capabilities.
• Genenta SciencestrategicStrategic or Co-development PartnerExpanded clinical viral development and manufacturing agreement for viral vector and cell therapy programs.
• The Jikei UniversitystrategicStrategic or Co-development PartnerExosome manufacturing agreement for idiopathic pulmonary fibrosis (IPF) project.
• Altheia SciencestrategicStrategic or Co-development PartnerGene therapy program at Milan facility using lentiviral vector and autologous CD34+ cells for modulating PD-L1 expression in treating autoimmune diseases.
• MediGenestrategicStrategic or Co-development PartnerTCR-T cell services agreement for new cell therapy product development.
• BioConnectionstrategicStrategic or Co-development PartnerStrategic partnership providing end-to-end biopharmaceutical drug substance and drug product development and manufacturing. Combined offering provides seamless 'gene-to-vial' services under single contract with AGC Biologics managing drug substance and BioConnection handling aseptic fill-finish.
• Thermo Fisher ScientificstrategicTechnology or IntegrationSupply agreement for Thermo Scientific 5,000-liter single-use bioreactors for Yokohama facility.
• CytivastrategicTechnology or IntegrationSupply agreement for FlexFactory platforms at Yokohama facility, including Xuri, Sepax C-Pro, VIA Freeze Duo/Quad, and VIA Thaw L1000 for mammalian mAb, mRNA, and cell therapy manufacturing.

Scale indicators22 records

Recent moves14 records

Expansion highlights5 records

Direct peers

• Lonza Group: The world's largest pure-play CDMO with a Biologics business spanning mammalian and microbial manufacturing, cell and gene therapy services, and a global multi-site GMP network. Lonza is the most direct comparable to AGC Biologics across modalities, scale, and customer base.
• Fujifilm Diosynth Biotechnologies: Major biologics CDMO offering mammalian and microbial contract development and manufacturing, with significant viral vector and cell therapy capabilities at large scale. Competes head-to-head with AGC Biologics for mammalian mAb and gene therapy outsourcing contracts.
• Samsung Biologics: Large-scale biologics CDMO with some of the world's biggest single-site mammalian bioreactor capacities. Directly comparable to AGC Biologics' mammalian mAb manufacturing offering and increasingly competing in ADC and complex biologics.
• WuXi Biologics: Global biologics CDMO with extensive mammalian and microbial manufacturing capacity and a viral vector platform. A direct competitor to AGC Biologics in mAb, bispecific, and viral vector manufacturing for global pharma and biotech customers.
• Boehringer Ingelheim BioXcellence: Biopharmaceutical contract manufacturing arm of Boehringer Ingelheim offering mammalian and microbial biologics, as well as viral vector services. Competes with AGC Biologics for commercial supply contracts from large pharma customers.
• Rentschler Biopharma: Mid-sized European CDMO focused on mammalian cell culture-based biologics and increasingly complex proteins and gene therapy. AGC Biologics' VP of European business development previously held a management role at Rentschler, underscoring direct competitive overlap.

Broad incumbents

• Thermo Fisher Scientific (Patheon): Diversified life sciences giant offering biologics CDMO services through its Patheon business alongside a much broader portfolio of tools, instruments, and clinical research services. Overlaps with AGC Biologics on biopharma services but operates at far greater scale across multiple categories.
• Charles River Laboratories: Diversified CRO/CDMO with biologics and cell and gene therapy manufacturing capabilities following acquisitions of Cobra Biologics and others. Overlaps with AGC Biologics on viral vector and cell therapy services but operates within a much broader discovery-to-manufacturing portfolio.

Others

• Catalent (Novo Holdings): Major CDMO with biologics, cell therapy, and viral vector capabilities following the Paragon and other gene therapy acquisitions. Now owned by Novo Holdings. Directly comparable to AGC Biologics across biologics and advanced therapies modalities.

Emerging players

• GenScript ProBio: Asia-headquartered CDMO offering plasmid DNA, viral vector, cell therapy, and biologics manufacturing services. An emerging competitor to AGC Biologics in the Asia-Pacific region with overlapping capabilities in gene therapy and nucleic acid manufacturing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/agcbiologics
• YouTubeyoutube.com/channel/UC-nYnVxmrMru_OHzX7KOnwg
• Facebookfacebook.com/AGCBiologics
• LinkedInlinkedin.com/company/agcbiologics

Revenue estimate

Valuation estimate

Number of profiles

Profiles18 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about AGC Biologics