Catalent

Catalent is a global Contract Development and Manufacturing Organization (CDMO) trusted by pharma, biotech, and self-care companies to accelerate product development, manufacturing, and delivery.

Core Services

Pharma Solutions:

• Small molecule development and manufacturing
• Biologics manufacturing including recombinant proteins and monoclonal antibodies
• Cell & gene therapy (CGT) manufacturing with dedicated Center of Excellence in Princeton, New Jersey
• Clinical supply services with specialized support for investigational medicinal products
• Advanced cell line development via GPEx® Lightning platform

Self-Care & Consumer Health:

• Over-the-counter medicines
• Dietary supplements (including soft chew formulations with cold-process technology)
• Skin, hair, and fragrance products
• Portfolio Accelerator™ program

Key Capabilities

• Process development and characterization
• Tech transfer and comparability protocols
• CGMP manufacturing across multiple dosage forms
• 500+ cell therapy batches manufactured; 80+ CAR-T/TCR programs supported
• Soft chew manufacturing at Manassas, VA facility (21 CFR 111 and 117 certified)
• Manufacturing by Design (MbD) methodology for process optimization
• Global regulatory expertise supporting BLA and MAA filings

Scale & Reach

• Nearly 40 sites worldwide
• 60+ billion doses delivered annually
• 1,000+ active development projects
• Assisted in half of all FDA approvals over the past decade
• 100+ new product launches and line extensions supported annually