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...
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...
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...
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
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
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 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...
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...
Pilot scale capacities in Zhangjiang, Shanghai Capable of generating 500-1000g of DS per batch to meet pre-IND and phase I &II clinical demand Aseptic fill 2- 20 ml vials, up to 900-1800 vial/hr and 5000 vials per batch; 2.8m² freeze-drying shelf area for DP GMP...
Our biologics analytical capability includes both analytical development and testing for non-GMP samples and QC testing and releases for GMP drug substances and drug product. Our rapidly growing Analytical Development & Quality Control team comprises 40+...
