cGMP Manufacturing

cGMP Manufacturing

Our Facility 67,000 m2 Strategically 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
cGMP Manufacturing

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
cGMP Manufacturing

Manufacturing Process Development and Scale-up

Cell culture process technology platform provides for the optimization of media, seeding densities, feeding and bioreactor process control strategies to maximize expression, and enhances process reproducibility and facilitate scale-up Adaption of cell line to...
Cell Line Development and Banking

Cell Line Development and Banking

Cell line development from DNA sequences to RCB stability assessment Traceability of host cell history and cell line generation process High productivity and robust stable cell line development platforms Well-equipped cell line development labs and clone...
cGMP Manufacturing

Developability Assessment

Watch our on-demand webinar: Biological Macromolecules: Exploring Analytical Development and QC Case Studies in Antibody Developability and Biologics CMC Presented by Dr. Jinghan Su, Assistant Director and Head of Developability, and Dr. Qian Sun, Director, Head of...
Epitope Binning by Octet Red 384

Epitope Binning by Octet Red 384

Classical sandwich assay format was selected for epitope binning using Octet Red 384. About nine bins were generated based on the result. Classical Sandwich Assay Sandwich format requirement: Ag reach equilibrium in 5 minutes Disassociation of Ag <50% in 10 minutes...