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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.

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.

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

Upstream Process Development Platform

Service Introduction

Stirred Cell Culture Platform

Orbital Shaken Cell Culture Platform

Downstream Process Development Platform

I. McAb Purification

II. BsAb Purification

III. Recombinant protein purification

Standard

Technology

Advantages