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Forge Biologics
Overview
Forge Biologics is a company based in Grove City, Ohio, specializing in the research and development of biologics, particularly in the field of adeno-associated virus (AAV) manufacturing. Founded in 2020, the company operates within the business services industry and employs between 201 and 500 individuals. Its primary focus is on late-stage process characterization for the commercialization of biologic products, emphasizing the importance of scalability, robustness, and regulatory compliance. In a recent technical report, Forge Biologics outlined its strategic approach to process development, highlighting the use of scale-down models (SDMs) that are proactively identified early in the program lifecycle. This methodology aims to compress timelines and reduce comparability risks during scale-up. The company emphasizes the necessity of demonstrating that SDMs are representative of commercial processes, integrating at-scale Good Manufacturing Practice (GMP) runs into SDM qualification to ensure that process characterization conclusions are supported by manufacturing-scale evidence. Forge Biologics' commitment to rigorous process development is evident in its focus on risk assessments and critical quality attributes throughout the product lifecycle.