Covance is one of the world's largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its discovery, nonclinical, clinical, CMC development and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Covance has the people, processes, client service, and global resource capabilities to respond to the toughest drug development challenges.
This is a focused introduction on the Covance CMC development capabilities for small and large molecules.
Small Molecule Chemistry, Manufacturing & Controls Development Services
In March 2011, Covance introduced a comprehensive and integrated set of Chemistry, Manufacturing & Controls (CMC) Pharmaceutical Development Services (PDS), including API development and supply, preformulation and formulation development, analytical and stability and regulatory documentation services.
Through this offering, which is built on the perfect combination of top-five pharma expertise, experience and facilities, and decades of excellent client service record, we are committed to helping pharmaceutical companies reduce the time required to prepare IND or NDA submissions, improve the hit rate of molecules and increase the likelihood of application approval on the first pass.
Biotechnology Services: Large Molecule CMC Analytical and Testing Services
With over 250 different biomolecules successfully supported annually, Covance offers you the most comprehensive biotechnology service in the industry.
Our experience covers a wide range of biomolecules, including recombinant proteins, monoclonal antibodies, vaccines, blood products, gene therapy products and more. Our capabilities include protein analytical chemistry, immunocharacterization, cell banking, biosafety testing, viral clearance, bioassay studies, molecular biology, stability and release, biomanufacturing support and more.
Customized and committed to clients large or small, Covance recognizes your development program is as unique as the products you bring to our facilities. You can choose to work with us on individual projects, milestone-based packages or full drug development solutions, whichever best fit the needs of your company and your molecule.
Regions covered:
Asia, North America, Europe, Latin America, and around the world.
Outsourcing services provided:
Development and Phase I/II CTM
- Injectable products development
- Solid dose, semisolids, and liquids development
- Process development – small molecule
Analytical Services
- Chemistry and stability
- Bioanalytical testing
- Biosafety and product characterization
- Microbiology
- Particle characterization
API Production Technologies
- Acetylenic chemistry
- Acid Chlorides
- Acylation
- Amidation
- Amino acids and analogs
- Asymmetric synthesis or chiral chemistry
- Azide chemistry
- Carbohydrate chemistry
- Chemocatalysis
- Cyanide chemistry
- Hydrazine chemistry
- Lithium chemistry
- Organometallic chemistry
- Nitration
- Sulfonation
Website:
www.covance.com/cmcpds
