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      • DMPK / Exploratory Toxicology
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      • Large molecule PK/BA services
    • Biologics Discovery
      • Antibody Discovery
      • Protein Science
      • Biologics Analytical Services
      • B Cell Cloning
    • Biologics CMC
      • Stable Cell Line Development
      • Process Development
      • Formulation Development
      • Aseptic Filling and Freeze-drying
      • Drug Developability / Manufacturability study
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      • Analytical Development and Testing
      • GMP Production
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Analytical Development and Testing

Home Analytical Development and Testing

Analytical Development and Testing

Our analytical capability includes both analytical development and testing for non-GMP samples and QC testing and release for GMP drug substance and drug product.  Our rapidly growing Analytical Development & Quality Control team comprises 40+ scientists (>60% with Ph.D. or M.S.) with combined experience of over 100 years in analytical development and over 70 years in the cGMP respectively. We apply the latest instrument to conduct a broad scope of analytical services for our clients from preclinical development, clinical trial, and commercial production. We are capable of developing most of analytical methods for therapeutic proteins, including but not limited to monoclonal antibodies, recombinant proteins, antibody drug conjugates, fusion proteins, and peptides. Our analytical team also supports regulatory submissions, such as IND or NDA, by providing required analytical method validation, testing and documentation.

Major analytical capability includes:

Characterization

  • LC-MS/MS (Thermo QE plus EMR, QE, Sciex 5600); CD (Jasco)
  • Sequence, PTM, Disulfide bond, Primary/Secondary structure

Biophysical Analysis

  • iCIEF (Maurice C); CE-SDS; SEC-SLS; CEX; DSC; DLS
  • PI, Aggregation, Degradation, Thermal & Colloid stability

Activity

  • Biacore (8K, T200, X100), Octet, FACS
  • Binding & Cell-based Activity
  • 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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