Service
CHO Cell Culture Process Development

Our aim is to provide all customers with biopharmaceutics-related services and products that enable a smooth transition between early R&D efforts to clinical trials and eventual commercial production. This transition relies on scaled-up and sustainable production processes. JSBio’s CHO cell culture process development platform provides our clients with a series of services including cell line development, development and optimization of cell culture medium formulation, process development and scale-up of the culture process, as well as many others tailored to suit your project needs. Our platform can assist you in:

  • Enhancing productivity

  • Improving product quality

  • Reducing the risk of contamination

  • Reducing cost

  • Accelerating the time required to market your product


CHO Cell Culture Process Development: Flexible Choice to Support Every Step
I.Cell Line Devlopment

Fexiable construction carrier: Cells

Gene Sequence provided: JSBio provides one-stop cell line construction service

Plasmid Provided: JSBio provides cell line construction and single clone selection

Transfected cells provided: JSBio provides single clone selection and stability validation


II.CHO Cell Culture Media Formulation Development and Process Optimization

The CHO cell culture medium formulation development process uses a high-throughput screening system and a DOE experimental design approach to optimize the process from TPP tubes and shaker bottles to 2L bioreactors.

 

Fed-batch culture process

  • Optimization of basal and feed medium formulations

  • Optimization of addition of Feed media strategy

  • Optimization of process parameters

Perfusion Process(Continuous Perfusion and Concentrated Fed-batch)

  • Optimization of Media formulations

  • Optimization of Perfusion Process parameters

III.CHO Cell Culture Process Scale-up

Our facility has a variety of bioreactor sizes for production of your biologics on the scale of 2 L, 15 L, 50 L, 300 L, 1200 L, as well as specialized scales to accommodate client needs. We possess a variety of bioreactor brands that are disposable and non-disposable. Our range of equipment provides a number of services to our clients, such as: scale-up, process characterization, process optimization, and final process verification.

IV.Clinical Filing Related Document Support
  • Media production batch records

  • cGMP documentation of the media development and optimization process

  • cGMP documentation of process development and optimization process

  • Pilot production batch records that meet regulatory filing requirements teansfer and other related documentation

  • Process development and trchnology transfer reports

  • Continuous technical support

  • Downstream process development