Process and Analytical Method Development

Home<Services<Process and Analytical Method Development
  • Developability Assessment
  • TOP clone screening
    (including stability evaluation)
  • High-throughput screening of culture media
    (domestic and imported)
  • Customized process optimization
    (Yield improvement & quality adjustment)
  • Fed-batch process development
  • Perfusion technology based process development
  • Process transfer and scale-up
Strengths and Capabilities
Rapid development
Start the process development from mini-pool;
Process development and locked, from shake flask to reactor can be completed in 8-12 weeks.
Excellent quality
Following the QbD concept and considering production cost, developing a stable, high yielding and competitive cell culture process;
Adhering to GLP principles, regulating the management of all nodes in the development process. For example, the authenticity and completeness of experimental records, the scientific and logical nature of report writing, etc.
Diversified and Scientific Process Development based on perfusion technology
Mastering more Know-How to continuously expand and improve upstream process development including control strategies and in process control, etc.
Demonstration Case

Customer 1

Requirements: Yield is 2.3 g/L, and needed to be improved while also reducing the proportion of acidic peaks in charge isomers and the content of Man5.

Difficulties: Time is tight, and there are batch to batch variation from technology transfer process. There are growth differences between shake flask and bioreactor processes, and the culture process is difficult to control.

  • High-throughput medium screening;
  • DOE experimental design is used in the shake flask process development stage to identify key factors that can increase yield and reduce Man5 content;
  • Cultivation parameters of bioreactor were explored synchronously, and the critical process parameters that affect cell growth were determined and scale-up successfully.

  • DOE experimental results (JPM software analysis)
  • Process optimization results

Project highlights

– Yield increased significantly to 4.5 g/L, Man5 content reduced to 3% and stable from batch to batch. Toxicology and GMP batch production have been completed and are consistent with the process development.

Customer 2

Requirements: Key clinical period changes, process optimization, cost reduction; quality consistency requirements.

Challenges: The early-stage project development is relatively complete, especially during medium screening stage, where imported media and mixing design have been tried. The original process is unstable after scale-up, and the yield is around 1.6-2.0 g/L. Project expected timeline is tight, with only 3 months from development to confirmation of scale-up process.

  • High-throughput screening of domestically produced media with different additives
  • Adjusting glycoform using platform method to reduce the Man5 content
  • Adjusting reactor process parameters to ensure consistency during process scale-up

Process optimization results

Project highlights

– yield increased to 4.2 g/L after scale-up in the bioreactor, and quality data were within the acceptable range; meanwhile, medium were replaced from imported medium to domestic medium to reduce the cost.