Forge Biologics

High-yield AAV manufacturing at scale with world-class cGMP compliance.

Listed on cdmo.directory

Dedicated AAV gene therapy CDMO with a 200,000+ sq. ft. cGMP facility featuring 20 suites and bioreactors up to 5,000L, supporting 60+ clients across 35+ indications with high-yield manufacturing and seamless regulatory compliance. Headquartered in Grove City, United States.

Modalities

Development & manufacturing

Structured CDMO capabilities from verified public sources.

Development (D)

Manufacturing (M)

Biologics / bioreactor infrastructure

Expression systems: Mammalian Cell-Free
Bioreactor type: Single-Use / Disposable Stainless Steel
Max bioreactor scale: Large commercial (≤10,000 L)

Fill-finish formats

Liquid Vials

Regulatory clearances

Services

Indications

About this organization

Overview

Forge Biologics is a specialized CDMO focused on accelerating gene therapy manufacturing, particularly AAV-based therapies. The company operates The Hearth, a 200,000+ sq. ft. cGMP manufacturing facility intentionally designed for scale, flexibility, and compliance.

Manufacturing Capabilities

AAV Manufacturing: High-yield AAV production with dedicated infrastructure and expertise across 35+ indications
Facility Scale: 20 cGMP suites with bioreactors ranging from 50L to 5,000L capacity
Batch Experience: 600+ batches manufactured to date
Client Base: 60+ clients supported across all development stages, with 97% utilizing Forge's proprietary technologies

Quality & Compliance

Comprehensive Quality Assurance aligned with cGMP standards and FDA/EMA regulatory requirements
Rigorous Quality Control embedded throughout manufacturing with multistep testing and environmental monitoring
Integrated quality systems spanning document control, deviation management, training, audits, CAPA, and electronic data integrity
Dedicated QA and QC teams supporting AAV and plasmid manufacturing with continuous monitoring and risk mitigation

Certifications

Authority	Identifier	Source
EU GMP	EU GMP Compliant	View
FDA	cGMP Compliant	View
EMA	EU GMP	View
FDA	cGMP	View
EMA	cGMP	View

Locations

Headquarters & Manufacturing (The Hearth)
Grove City · Ohio · United States
Headquarters & Manufacturing
Grove City · Ohio · United States
The Hearth (Manufacturing Facility)
The Hearth (Manufacturing Facility)
United States

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