Biologics CMC Analytical Development and Testing

Biologics CMC Analytical Development and Testing

ChemPartner’s analytical capability includes analytical development testing for non-GMP samples, GMP drug substances, and drug product release and stability testing as well as extended product characterization.  Our rapidly growing analytical development and quality...
Biologics CMC Analytical Development and Testing

cGMP Manufacturing

67,000 m2Strategically located in Qidong, Jiangsu 45 minutes from the Shanghai Free Trade Zone 50 minutes from the Shanghai Pudong International Airport 1.5 hours from ChemPartner’s Zhangjiang Site Take the Virtual Tour Phase I mAb Production Plant...
Pilot-Scale Production

Pilot-Scale Production

ChemPartner’s pilot-scale Drug Product service experts manufacture cGMP compliant liquid and lyophilized drug product. Aseptic drug product manufacturing includes selection and qualification of the primary packaging materials, process development, manufacturing of...
Extractables and Leachables

Extractables and Leachables

Services include: Extractables and leachables studies using various platforms of GC-FID, GC-MS-MS, ICP-MS, LC-MS-MS, and UPLC, etc. Safety assessment of extractables and leachables
Biologics CMC Analytical Development and Testing

Biologics CMC Formulation Development

Services include: Formulation screening for liquid and lyo products Container closure evaluation and selection  Lyophilization process development and scale-up Stability studies of drug substance and drug product