Covance offers you the expertise and optimal solutions relating to the synthesis, characterization, formulation and scale up of your Active Pharmaceutical Ingredient (API). Statistically, 20% of drug failure is associated with API development, especially during the preclinical stages. With Covance as your API development partner, you benefit from our experience and partnership.
Covance provides you with a broad scope of API development services, from design to synthesis with full analytical characterization. The industry-leading specialties in crystal engineering, physical and molecular characterization, salt screening and polymorph screening are all available to you. Our CMC facilities are fully GMP compliant.
Center of Excellence. Our Porcheville, France, site is an API Center of Excellence that offers over 20,000 sq. ft. (2,000 m2) of modern laboratory space and over 10,000 sq. ft. (1,000 m2) of pilot plants dedicated for API development.
Your API Development Team. Covance has your big picture in mind. We will provide you with a group of scientists who have extensive real-life experience moving API from lab-scale synthesis to product commercialization. They accomplish this through established team synergy and by working directly with teams from discovery, preclinical, clinical, regulatory and product marketing functions
Capabilities designed for your success include:
- API process development
- Discovery route assessment
- Route scouting
- Lab scale API batch manufacture
- IND route development
- Primary reference synthesis & characterizations
- Preparation of major impurities in API and characterizations
- NDA route development
- Process safety studies
- Process development to support multi-kilo manufacture with optimization
- API preformulation
- Crystallization process development leading to the desired API physico-chemical properties.
- API synthesis and supply
- API analytical development and support
- API characterization
- Elemental analysis
- Spectroscopic methods (IR, UV-VIS, NMR, Mass Spec)
- Purity (HPLC, GC, LC/MS/MS, etc.)
- Chirality (optical rotation)
- Residual solvents & water content
- Thermogravimetry, DSC (Endothermic/ Exothermic properties)
- SEM (scanning electron microscope)
- Optical microscopy
- Particle size distribution
- Crystalline vs. amorphous by X-ray powder diffraction (XRPD)
- Polymorphism by X-ray powder diffraction (XRPD)
- Stability (susceptibility for oxidation, hydrolysis, photochemical reactions, etc.)