Technology

Cell platform downstream process development and optimization technical services

 

Cell platform downstream process development and optimization technical services

This platform mainly provides services for small-scale process development and pilot-scale production of animal cell culture products (protein or nucleic acid), including: optimization of solid-liquid separation process, optimization of chromatography process, optimization of virus removal process, and stable production of pilot-scale production. In order to achieve the purpose of improving yield, enhancing process robustness and assisting customers to achieve process scale-up; conduct sufficient quality research and tracking of the process according to relevant regulatory requirements. The platform combines the needs of customers and integrates the concept of quality by design (QbD) into the process of each process development to provide customers with high-quality technical services.

 

Service Items

 

  • Ⅰ

    Solid-liquid separation process optimization

  • Ⅱ

    Chromatography Process Optimization

  • Ⅲ

    Devirus process optimization

  • V

    Pilot process development

  • Ⅳ

    Process Characterization Studies

Service Advantage

 

· Technical team with rich experience in biological drug purification process development

· Have R&D and production conditions from 10L to 2000L that meet GMP conditions

· Possess a quality management system that conforms to Sino-US dual reporting