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    • Discovery Chemistry
      • Synthetic Chemistry
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      • Fragment Based Screening
      • Computer Aided Drug Design
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    • Biology & Pharmacology
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      • Pathology Core Facility
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    • DMPK / Exploratory Toxicology
      • DMPK / Exploratory Toxicology
      • Biomarkers, Preclinical & Clinical Sample Bioanalysis
      • Large molecule PK/BA services
    • Biologics Discovery
      • Antibody Discovery
      • Protein Science
      • Biologics Analytical Services
      • B Cell Cloning
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      • Stable Cell Line Development
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      • Formulation Development
      • Aseptic Filling and Freeze-drying
      • Drug Developability / Manufacturability study
      • Final Container Extractables & Leachables Study
      • Analytical Development and Testing
      • GMP Production
    • Small Molecule CMC
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Manufacturing

Home Small Molecule CMC Manufacturing

Manufacturing

Our primary manufacturing facilities are located in the Fengxian Industrial Park in the greater Shanghai area. The facilities have been fully GMP operational since 2011. The highly experienced technical and plant operation teams, including project management and customer service teams, have the expertise and experience to ensure a seamless process development/technical transfer and scale-up to commercial manufacturing quantities as programs advance in their development to commercial launch.

  • Scale-up capabilities in the Kilo-Lab and Pilot Plant
  • Cryogenic, pressure (including hydrogenation and carbonylation) and high temperature capabilities
  • Large scale manufacturing of high value intermediates, Registration Starting Materials and APIs from the kilogram to ton scale under both non-GMP and GMP conditions supporting GLP Toxicological studies through Phase I-III clinical studies and commercial launch.

The second phase build-out of the Fengxian facility is under way and includes construction of commercial manufacturing facilities. This will add considerable capacity to our existing chemical development and manufacturing capabilities.

  • Service Overview
  • Discovery Chemistry
    • Synthetic Chemistry
    • Medicinal Chemistry
    • Library Chemistry
    • Peptide Chemistry
    • Fragment Based Screening
    • Computer Aided Drug Design
    • Analytical Services
    • Protein Structure
  • Biology & Pharmacology
    • Oncology
      • OncoCP Database
    • Pathology Core Facility
      • Histopathology
      • Molecular Pathology
    • Immunology
      • Primary immune cell assays
      • Immune cell line assays
      • Autoimmune disease models
      • In vivo PD models
      • Immune profiling for MOA
    • Tumor Immunology
    • Neuroscience
      • Volume Discount Fast services for Neuroscience
      • Behavioral Pharmacology
      • In vivo Pain Models
      • Non-Human Primate Cognition
      • In Vitro Electrophysiology
    • Cell Biology
      • Target Validation
      • Cell-based Assays
      • Cancer Cell Line Panel Screen
      • Biomarker Analysis
    • In Vitro Biology
      • Kinases
      • Epigenetics
      • GPCR, NR, Ion-channel, Transporter
      • Ubiquitin & PROTAC
      • KRAS
      • COVID-19
      • Radiometric
      • Customized assay development
      • High throughput screening
      • MOA Study
    • Metabolic & Cardiovascular Diseases
  • DMPK / Exploratory Toxicology
    • DMPK / Exploratory Toxicology
      • In vitro ADME
      • Pharmacokinetics
      • Exploratory Toxicology
      • Bioanalysis
      • Regulatory filing
    • Biomarkers, Preclinical & Clinical Sample Bioanalysis
    • Large molecule PK/BA services
      • Monoclonal Antibodies
      • Antibody Drug Conjugates
      • Bispecific Antibodies
      • Proteins & Peptides
      • Immunogenicity
  • Biologics Discovery
    • Antibody Discovery
      • Hybridoma
      • Antibody Engineering
      • Phage Display
      • Antibody-Drug Conjugate
    • Protein Science
    • Biologics Analytical Services
      • mAb Release Tests and Extended Characterization
      • Antibody-Drug Conjugate(ADC) Analysis
      • Therapeutic Protein Characterization
      • Biomolecular Interaction Analysis
    • B Cell Cloning
  • Biologics CMC
    • Stable Cell Line Development
    • Process Development
    • Formulation Development
    • Aseptic Filling and Freeze-drying
    • Drug Developability / Manufacturability study
    • Final Container Extractables & Leachables Study
    • Analytical Development and Testing
    • GMP Production
  • Small Molecule CMC
    • Process R&D Services
    • Process Safety
    • Analytical Development
    • Pre-Formulation Development
    • Formulation Development
    • ICH Stability Studies
    • CMC CTD Support
    • Manufacturing

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