Capitol Biologics

Overview

Capitol Biologics describes itself as a full-service CDMO supporting the R&D and early-phase clinical trial manufacturing needs of emerging biotech firms. The company focuses on quality-driven biologic, protein, and monoclonal antibody drug development, from cell line development through GMP manufacturing.

Services

• Cell line development, including stable cell line production and cell line workflow.
• Process development, including process development and scale-up, bioprocess development, and a bioprocessing platform.
• Analytical development and product characterization, including comprehensive analytical services, compendial methods, qualified analytical methods, characterization methods, and cell-based assays.
• GMP manufacturing, including a manufacturing platform, clinical drug substance manufacturing, and process validation.
• Formulation and drug product development, as referenced in the Cell Line, Process & Product Development service area.
• QC testing and quality assurance, including release and stability testing, quality control, and a quality management system.

Differentiation

The company cites a proven track record in biologics development and manufacturing, single-use technology and scalable platforms, and deployment of next-generation continuous manufacturing processes. Its stated approach is phase-appropriate and fit-for-purpose, with an emphasis on efficient delivery.

Background

Capitol Biologics is described as a new venture from BioFactura, a company founded in 2004 that focuses on small-scale biologics development and manufacturing.