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Upstream Process Development Platform

Service Introduction

Media and feed screening platform
Protein Quality Assessment (charge variants, glycosylationand aggregates)
Stirred bioreactor process development
Orbital Shaken bioreactor process development
Perfusion process platform
Intensified Fed-batch culture



Stirred Cell Culture Platform

TOP cloning bioreactor culturing evaluation, 3-15L scale culturing process development system.

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Orbital Shaken Cell Culture Platform

The novel bio-reacting and amplification system isjointly developed between Canton Biologics and the world's top bioreactor supplier Kuhner. It is more suitable for shear-sensitive protein manufacturing, providing a more stable culturing environment for easily degradable and easy-to-aggregate proteins. The system has excellent scale-up consistency from lab scale to batch manufacturing scale.

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Downstream Process Development Platform

  • I. McAb Purification

    Conventional affinity chromatography purification
    Cost effective purification w/o affinitychromatography
    Membrane chromatography purification
  • II. BsAb Purification

    Aggregate removal
    Product related impurities removal (mismatched and incomplete antibody fragments)
    Mild purification condition to maximize protein stability
  • III. Recombinant protein purification

    Diversified virus inactivation protocols
    Appropriate protein capture strategies
    Multiple protocols to maximize protein stability
  • Standard

    Follow CDE and ICH Guideline
    Utilize QbD development concepts
    Apply HTPD and DOE tools
  • Technology

    Chomatography techniques
    Filtering technology
    Virus inactivation/removal technology
  • Advantages

    Recombinant protein purification
    Bispecific antibody purification
    Maximum protein stability
      


Liquid Formulation Development Platform

Liquid Formulation Development Platform

Rich project experience and strong regulatory track record
High-throughput analytical technology for fast formulation screening
Particle broad-spectrum detection

Lyophilization Formulation Development Platform

Quick solution to develop stable formulation
Lyophilization process development
Testing of critical formulation temperature
Determination of water content

Inhalation Formulation Development Platform

Innovative delivery of inhaled biologics
Inhalation formulation development
Nebulizer screening
Inhaled aerosol characterization

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