Forge Biologics

What Forge Biologics does

Forge Biologics is a US-based gene therapy contract development and manufacturing organization (CDMO) founded in 2020 and headquartered at a 200,000+ sq ft custom-designed cGMP facility called "The Hearth" in Grove City, Ohio. The company serves gene therapy developers across academic researchers, nonprofit foundations, clinical-stage biotechs, and pharmaceutical companies, offering end-to-end AAV services from molecular development and process development through cGMP manufacturing, analytical testing, fill-finish, stability, and regulatory support. Disclosed scale metrics include 60+ clients supported, 600+ batches manufactured, 35+ therapeutic indications, and a workforce of nearly 400 experts of which 30% is dedicated to Quality Management.

The company's core technology is the proprietary FUEL™ AAV Manufacturing Platform, launched in October 2024, which combines three Forge-developed components: HEK293 suspension Ignition Cells™, the pEMBR™ 2.0 adenovirus helper plasmid (8.9 kb, one of the smallest commercially available), and patent-pending modified rep/cap plasmids. FUEL™ is reported to deliver 6–22x productivity gains versus industry standard processes when combined with product-specific optimizations, and 97% of Forge clients adopt the platform technologies. Operational scale includes 20 cGMP suites, 20,000L of bioreactor capacity at 50–5,000L scale, integrated fill-finish, 25+ in-house AAV assays, and AAV and plasmid Drug Master Files maintained in the US and Canada with EU GMP compliance.

The business model is project-based, quote-driven CDMO services with multi-year statements of work spanning research-grade (Blaze offering at 1–40L), process development, toxicology, and cGMP commercial manufacturing, with recurring revenue tied to long-duration programs. Forge was acquired by Japan's Ajinomoto Co., Inc. for $620 million in December 2023 and now operates as a wholly-owned subsidiary under Ajinomoto Bio-Pharma Services, alongside sister CDMO sites in Belgium, India, and Japan. Distribution is exclusively direct: enterprise field sales targeting biotech and pharma with a dedicated Client Relations Manager, Project Manager, and Technical Sales & Scientific Advisor per program, plus inside-sales/web-form intake for early-stage researchers via the Blaze offering.

Name

Forge Biologics

Legal name

Forge Biologics, Inc.

Website

https://forgebiologics.com

Company type

Private

Founded year

2020

Operating status

Acquired

Headcount range

251–500 employees

Short description

Forge Biologics is a US-based AAV gene therapy contract development and manufacturing organization (CDMO) providing end-to-end services from molecular development through cGMP manufacturing at its 200,000+ sq ft Ohio facility, serving biotech, pharma, foundation, and academic clients. Wholly-owned subsidiary of Ajinomoto Bio-Pharma Services.

Ownership category

akta.pro rank

Product category

Gene Therapy CDMO Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE)

akta.pro secondary industries

Gene Therapy Vector Manufacturing & CDMO Services (HLAAACAJ), Gene Therapy CMC/Process Development Platforms (capsid engineering, producer cell lines, plasmids, upstream/downstream) (HLAAACAN), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Process Development & Tech Transfer Services (CDMO) (HLAGABAL)

Keywords

• AAV gene therapy manufacturing
• Viral vector CDMO services
• Biologics contract manufacturing
• CGMP plasmid production
• Gene therapy development

Headquarters

HQ city

Grove City

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Gene Therapy CDMO Services: End-to-end contract development and manufacturing services for AAV gene therapies — including research-grade production, process and analytical development, cGMP manufacturing (50–5,000L), fill-finish, stability, and integrated regulatory support. Revenue is project-based, governed by statements of work, with multi-year scope across clinical phases and ongoing revenue from long-duration programs.
2. Managed cGMP Manufacturing: Long-term managed manufacturing services for client gene therapy programs across the product lifecycle (clinical through commercial), leveraging the 20,000L of bioreactor capacity across 20 cGMP suites. Recurring revenue tied to batches, suites, and long-running programs (typical CDMO managed services structure).
3. Technology Licensing / Platform Adoption: Adoption of FUEL™ platform technologies (pEMBR™ 2.0, Ignition Cells™, modified rep/cap) — 97% of clients use Forge's proprietary technologies — implying platform-driven technology value capture within CDMO contracts and potential co-development/licensing arrangements.

Pricing tiers

Go-to-market motion4 records

Distribution channels3 records

Marketing channels9 records

Core offering

Forge Biologics is an AAV-focused gene therapy contract development and manufacturing organization (CDMO) offering end-to-end services from molecular development and research-grade production through process development, cGMP manufacturing (50–5,000L), analytical development, fill-finish, stability, and regulatory support. All work is delivered under the proprietary FUEL™ platform combining HEK293 Ignition Cells™, pEMBR™ 2.0 Ad helper plasmid, and modified rep/cap plasmids, executed at the 200,000+ sq. ft. Hearth facility in Columbus, Ohio.

Product overview

Forge Biologics is a US-based gene therapy contract development and manufacturing organization (CDMO) offering end-to-end AAV manufacturing services through an integrated platform-plus-modules architecture. The core platform is the FUEL™ AAV Manufacturing Platform, which combines proprietary technologies (HEK293 suspension Ignition Cells™, pEMBR™ 2.0 Ad helper plasmid, modified rep/cap plasmids, and improved analytics) with proven processes and product-specific optimizations to deliver up to 6-22x productivity increases over industry standard. Surrounding service modules include Blaze Vector Production (research-grade AAV at 1-40L), Process Development (upstream/downstream optimization with 50+ mapped studies), cGMP Manufacturing (50-5,000L scale), Analytical Development & Quality Control (25+ in-house AAV assays), Fill-Finish, Stability testing, Molecular Development consultation, Technology Transfer, Regulatory & Quality Support, and Viral Vector Services that bundle the full end-to-end offering. All activities are conducted at the Hearth, Forge's 200,000+ sq ft custom-designed cGMP facility in Columbus, Ohio with 20 cGMP suites and bioreactors from 50L to 5,000L. Forge is a member of Ajinomoto Bio-Pharma Services following its December 2023 acquisition, and its Quality Unit (representing 30% of staff) is integrated with Veeva Quality, Veeva LIMS, and Veeva RIM systems.

Differentiator

Problem solved

Functional benefit

Brands

• FUEL™ Platform: Forge's proprietary AAV manufacturing platform combining pEMBR™ 2.0 Ad Helper, modified rep/cap plasmids, and HEK293 suspension Ignition Cells™, designed to increase AAV productivity and recovery.
• Blaze Vector Production

Products and services

• FUEL™ AAV Manufacturing Platform Forge's proprietary AAV manufacturing platform combining pEMBR™ 2.0 Ad helper plasmid (8.9 kb), HEK293 Ignition Cells™ (over 90% full capsids post-enrichment), modified rep/cap plasmids, and improved analytics. Targets gene therapy developers seeking scalable, commercially viable AAV production across all serotypes including novel capsids.
• Blaze Vector Production Research-grade AAV production offering at 1–40L scale for early-stage discovery and proof-of-concept studies, leveraging FUEL™ platform technologies (HEK293 Ignition Cells™, pEMBR™ 2.0 Ad helper, modified rep/cap plasmids) with seamless scale-up to cGMP.
• Process Development

Quantifiable outcome

• FUEL™ platform increases AAV productivity 6–22x compared to industry standard (and 2–6x in earlier published benchmarks)
• +6 more outcomes

Named customers9 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability1 record

Feature9 records

Partnerships

15 partnerships are on record, tiered flagship — recent flagship clinical-stage manufacturing partnership and primary news headline on forge homepage, flagship — recent multi-program manufacturing partnership with clinical-stage client, flagship — high-visibility rare-disease foundation partnership under prf's path to cure progeria initiative, flagship — strategic manufacturing partnership with clinical-stage rna editing biotech, flagship — sibling-subsidiary co-development under the ajinomoto group umbrella, core — strategic aav development and cgmp manufacturing partnership, core — clinical-stage gene therapy platform partnership, core — pipeline-spanning aav cgmp manufacturing partnership, core — quality systems backbone across the hearth, minor — patient advocacy/community partner, minor — industry/community partner, core — industry advocacy partner; forge co-hosts arm webinars and forge ceo previously served on arm board, core — primary scientific conference partner, minor — industry consortium partner and minor — industry/manufacturing consortium partner.

• Skylark Bioflagship — recent flagship clinical-stage manufacturing partnership and primary news headline on forge homepageStrategic or Co-development Partner · 16 June 2026Strategic AAV development and cGMP manufacturing partnership supporting Skylark's clinical development. Under the partnership, Forge is providing Skylark with process development, cGMP manufacturing, and analytical development services, including leverage of the FUEL™ platform technologies (HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid). All development and manufacturing activities are conducted at the Hearth in Columbus, Ohio. Skylark's lead program SKY-GJB2 is in a Phase 1/2 clinical trial for GJB2-related hearing loss — the leading genetic cause of inherited hearing loss worldwide.
• Epicrispr Biotechnologiesflagship — recent multi-program manufacturing partnership with clinical-stage clientStrategic or Co-development Partner · 5 May 2026Strategic AAV development and cGMP manufacturing partnership to support the development and manufacturing of EPI-321, Epicrispr's investigational AAV gene therapy for facioscapulohumeral muscular dystrophy (FSHD). Forge is providing AAV process development, cGMP manufacturing, and analytical development services, leveraging FUEL™ platform technologies (HEK293 Ignition Cells™, pEMBR™ 2.0, and optimized AAVrh74 rep/cap). Material manufactured at Forge supports a first-in-human clinical trial across the U.S., New Zealand, and Australia, adding to Forge's APAC clinical experience.
• The Progeria Research Foundation (PRF)flagship — high-visibility rare-disease foundation partnership under prf's path to cure progeria initiativeStrategic or Co-development Partner · 3 March 2026Manufacturing partnership to support development and manufacturing of SamPro-2, an investigational AAV9 gene therapy using base-editing technology for Hutchinson-Gilford Progeria Syndrome. Forge provides process development, cGMP manufacturing, FUEL™ platform technologies, and regulatory consultation for IND-enabling studies. The Progeria Gene Team is led by Leslie Gordon (PRF), David Liu (Broad Institute), and Francis Collins.
• Ascidian Therapeuticsflagship — strategic manufacturing partnership with clinical-stage rna editing biotechStrategic or Co-development Partner · 7 January 2026Strategic manufacturing partnership to advance ACDN-01, Ascidian's lead retinal RNA exon-editing program for Stargardt disease (Phase 1/2 STELLAR trial). Forge provides process and analytical development services, toxicology, and cGMP manufacturing, leveraging FUEL™ technologies including HEK293 Ignition Cells™ and pEMBR™ 2.0, with program-specific optimizations. All activities take place at the Hearth. Collaboration secures clinical supply needed to advance ACDN-01 into late-stage studies.
• Ajinomoto CELLiST Korea (Ajinomoto Group subsidiary)flagship — sibling-subsidiary co-development under the ajinomoto group umbrellaStrategic or Co-development Partner · 11 December 2025Co-developed CELLiST™ AAV Production Supplement 1, a new medium supplement that improved viral vector productivity 1.3–2x vs conventional methods, combining Ajinomoto's formulation optimization technologies with Forge's experience in large-scale AAV manufacturing. Ajinomoto CELLiST Korea will primarily support customers in Asia. The supplement addresses manufacturing challenges as the global gene therapy market is projected to grow from USD 7 billion in 2022 to USD 46 billion by 2030.
• Avista Therapeuticscore — strategic aav development and cgmp manufacturing partnershipStrategic or Co-development Partner · 13 August 2025AAV development and cGMP manufacturing partnership to advance AVST-101, Avista's lead gene therapy for X-linked retinoschisis (XLRS). Avista is leveraging Forge's FUEL™ platform to manufacture AAV, including HEK293 suspension Ignition Cells™ and proprietary technologies. Avista is a pre-clinical-stage biotechnology company developing novel AAV capsids with high efficacy and unique tropisms for rare ophthalmic conditions.
• Fractyl Healthcore — clinical-stage gene therapy platform partnershipStrategic or Co-development Partner · 14 May 2025AAV development and cGMP manufacturing relationship to advance Fractyl's Rejuva pancreatic gene therapy platform for patients with metabolic diseases. Fractyl will leverage Forge's FUEL™ platform to manufacture AAV.
• Affinia Therapeuticscore — pipeline-spanning aav cgmp manufacturing partnershipStrategic or Co-development Partner · 13 November 2024AAV cGMP manufacturing partnership to advance Affinia's pipeline of next-generation gene therapies — including a program for cardiomyopathy — into the clinic.
• Veeva Systemscore — quality systems backbone across the hearthTechnology or IntegrationTechnology partner providing Veeva Quality Cloud (Quality, LIMS, RIM) that underpins Forge's Quality Management operations — including document control, deviation management, training, audits, CAPAs, change controls, and electronic data integrity. Forge is cited as a CDMO case study demonstrating reduced lead times, improved audit readiness, and simplified approval workflows through Veeva's external collaboration features.
• Muscular Dystrophy Association (MDA)minor — patient advocacy/community partnerGTM or Marketing PartnerIndustry advocacy and community partnership; MDA logo displayed on Forge's About page among 'groups helping make it possible'.
• California Institute for Regenerative Medicine (CIRM)minor — industry/community partnerGTM or Marketing PartnerIndustry/community partnership; CIRM logo displayed on Forge's About page among 'groups helping make it possible'.
• Alliance for Regenerative Medicine (ARM)core — industry advocacy partner; forge co-hosts arm webinars and forge ceo previously served on arm boardGTM or Marketing PartnerTrade organization partner; ARM logo displayed on Forge's About page; John Maslowski previously served on the board of the Alliance for Regenerative Medicine; Forge participates in ARM webinars including 'Tackling CMC Challenges'.
• American Society of Gene and Cell Therapy (ASGCT)core — primary scientific conference partnerGTM or Marketing PartnerAnnual presenting/exhibiting partner at ASGCT meetings — delivered 7 presentations at the 29th Annual Meeting (Boston, May 11-15, 2026) and 8 presentations at the 28th Annual Meeting. ASGCT logo displayed on Forge's About page.
• Bespoke Gene Therapy Consortium (BGTC)minor — industry consortium partnerGTM or Marketing PartnerIndustry consortium partnership; BGTC logo displayed on Forge's About page among 'groups helping make it possible'.
• NIIMBL (National Institute for Innovation in Manufacturing Biopharmaceuticals)minor — industry/manufacturing consortium partnerGTM or Marketing PartnerIndustry consortium partnership; NIIMBL logo displayed on Forge's About page among 'groups helping make it possible'.

Scale indicators13 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Lonza Group: One of the world's largest CDMOs with established cell and gene therapy capabilities including viral vector manufacturing at multi-site scale. Competes with Forge for AAV programs but offers broader modality coverage and global redundancy that Forge lacks.
• Catalent (Novo Holdings): Major CDMO with viral vector and cell therapy manufacturing capabilities, including AAV services, serving biotech and pharma clients globally. A direct competitor for large AAV programs given its multi-site scale and integrated fill-finish.
• Charles River Laboratories: Large CDMO with viral vector manufacturing services and end-to-end cell and gene therapy offerings, including plasmid production. Competes with Forge on AAV CDMO engagements, particularly for clients seeking a single CRO/CDMO relationship.
• AGC Biologics: Global CDMO with mammalian and viral vector manufacturing capabilities, including AAV and lentivirus production, with sites in the US and Europe. Competes with Forge for clinical and commercial AAV manufacturing contracts.

Direct peers

• Andelyn Biosciences: Pure-play AAV and viral vector CDMO spun out of Nationwide Children's Hospital in Columbus, Ohio, with cGMP manufacturing and process development services. The most direct competitor to Forge, sharing the same Columbus gene therapy ecosystem and AAV focus.
• Yposkesi: European AAV and viral vector CDMO (formerly Généthon) with cGMP manufacturing capacity for gene therapy programs. Direct competitor for European and transatlantic AAV manufacturing contracts, particularly those requiring EU GMP.
• VGXI: Specialized plasmid DNA and viral vector CDMO with cGMP manufacturing capabilities serving gene therapy developers. Competes with Forge on the upstream plasmid and viral vector manufacturing portion of AAV programs.
• Biovian: European CDMO specializing in viral vector (AAV, lentivirus) and microbial manufacturing for gene therapy and vaccine developers. A direct competitor for clients seeking single-site AAV manufacturing with EU GMP compliance.

Emerging players

• Aldevron (Danaher): Plasmid DNA, mRNA, and protein CDMO now part of Danaher's Cytiva life sciences business, serving gene therapy developers with upstream biological materials. Adjacent competitor for clients sourcing plasmids and raw materials for AAV production.
• Vineti: Cell and gene therapy supply chain and orchestration platform (part of the October 2024 merger with Lanser CDMO). Adjacent ecosystem participant that competes with CDMOs on integrated therapy delivery rather than direct AAV manufacturing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xfacebook.com/forgebiologics
• YouTubeyoutube.com/@forgebiologicsofficial
• Facebookfacebook.com/Forge-Biologics-100590728167655
• LinkedInlinkedin.com/company/forge-biologics

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries1 record

Funding overview

Funding rounds5 records

Investors9 records

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

M&A

Investments

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

Frequently asked questions about Forge Biologics