Highly Potent Active Pharmaceutical Ingredients
HPAPI, HORMONE, AND CYTOTOXIC HANDLING CAPABILITIES
Catalent is the #1 Drug Development, Delivery and Supply Partner for the global pharmaceutical and biotech industries. With over 20 years of experience in potent handling and more than 80 years in pharmaceutical delivery solutions, Catalent offers integrated analytical, development, manufacturing and clinical supply solutions for highly potent products.
Catalent’s long history of expertise in handling high potent molecules includes more than 300 Category 3 & 4 compounds across 12 sites in the global Catalent network, including hormones and cytotoxics. Catalent has also recently invested in its Somerset, NJ Headquarters as a Center of Excellence for Oral Solid Potent Manufacturing
HIGHLY POTENT SOLUTIONS OVERVIEW
From API optimization, particle size optimization and formulation services, to drug delivery technology and final dose form design services, Catalent can help you at the earliest stages of the drug development process and provide end-to-end solutions to accelerate your programs to clinic and to market, utilizing our broadest expertise, best technologies and rigorous science.
- Global supply chain expertise
- Development
- Analytical services
- Delivery technologies
- Clinical and commercial manufacturing
- Packaging services
- Clinical storage and distribution
- Highly potent, hormonal, cytotoxic compounds
- Multiple oral dose form technologies and services
- Robust controls for special handling and containment
- Engineering and PPE controls
- Comprehensive risk assessment processes
- Highly-trained and experienced personnel
- Expertise in special handling protocols
- Controlled substance handling (DEA I-V)
BROAD RANGE OF ORAL TECHNOLOGIES
EXTENSIVE SUITE OF ORAL MANUFACTURING CAPABILITIES
- Tableting and capsule filling
- Particle Size Engineering
- Hot-Melt Extrusion
- Catalent Spray Drying Technology
- High-shear and wet granulation processing, solvent-based capability
- Fluid-bed processing, Wurster coating
- Compression and encapsulation
- Extrusion/spheronization
- Blending and milling
FACILITIES WITH POTENT HANDLING CAPABILITIES
Our high potent handling facilities have strong track records for both quality and regulatory compliance.
Oral Solids Development and Manufacturing
Softgel Technologies
Stand-Alone Analytical Services
Clinical Supply
All molecules have a challenge. We have a solution. For an expert consultation of how we can assist with your highly potent molecule challenges contact us and an expert will get back to you shortly.