Putting Science to Work
Process Development

Process Development

Upstream & Downstream Process Development

Competent approach with advanced technologies and precise process controls ensure the significant enhancement of protein expression. Our process development is always geared towards obtaining desired growth, productivity and purity. High throughput screening of upstream parameters and downstream unit operations are followed to reduce time lines.

Achieving the desired results with compressing time lines and reduced costs for the development is a key offering by Syngene. We assure that process developed at Syngene is rapidly translated into a robust, scalable and economical process suitable to be transferred to GMP and validated.

The step wise approach taken during process development is briefly mentioned below:

Upstream process development
  • Bioreactor evaluation of the selected clones
  • Culture conditions identification and improvement
  • Feeding regime optimization
  • Design of Experiments (DOE) and process modelling approaches at different stages of development
  • Process troubleshooting for quality, yield and robustness
  • Support for scale-up to plant bioreactor scale
Downstream process development
  • Single/multiple unit operation development and optimization
  • FMEA for CQA in a given unit operation
  • Process scaled-down model and qualification
  • Process characterization (statistical approach) and validation studies
  • TTD preparation and Process transfer to other manufacturing sites
  • Support for process scale-up to bioreactor scale

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