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Process Development

Home Process Development

Process Development

  • Cell culture process technology platform provides for optimization of media, seeding densities, feeding and bioreactor process control strategies to maximize expression, enhance process reproducibility and facilitate scale-up.
  • Adaption of cell line to suspension culture process
  • Adaption of cell line to serum-free/animal protein-free media
  • Media optimization and evaluation
  • Development of Fed-batch bioreactor process
  • Cell culture characterization and optimization
  • Scale-up
  • Analysis of risk and cost benefits for various types of cell culture processes

Mammlian Cell Culture Systems:

  • Flasks (all types)
  • Spinner / Shake Flasks
  • Wave- and Stir-Form Bioreactors
  • 3L & 15L bioreactors (Applikon)
  • 2 x Wave-form Bioreactors: 2L – 25L capacity(GE)
  • 1 x 50-liter & 1x200L&1 x 250L Single-Use Bioreactor(Hyclone & GE)
  • Cell Culture Analyzers
  • 1 x Bioprofile Flex2 (Nova Biomedical)
  • 1 x Bioprofile 400 (Nova Biomedical)
  • 1 x Vi-Cell (Beckman Coulter)
  • Cell Culture Clarification
  • Depth Filtration
  • Centrifugation

The platform process for MAb is:

  • Depth filtration
  • Pro A + low pH inactivation + filtration
  • Cation or Anion exchange chromatography
  • Virus filtration
  • Ultra-filtration
  • Use this process to remove HCP/HCDNA/Aggregation and control charge variant.
  • During process development, each unit operation CPP will be developed with design space.
  • Linear scale up from bench to 10, 50 and 250L related scale, the process description will be transferred into batch records for pilot scale.
  • All the CQAs and recovery will be monitored during scale up to dial in the TPP.

  • 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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