Putting Science to Work

Process Development and Scale-up

Syngene’s formulation development centre has state-of –the-art infrastructure and equipment to support process development and scale-up for various manufacturing processes over a broad scale range (0.1 kg-50 kg for oral solids).

This is achieved through:
  • Direct compression
  • Dry granulation – roller compaction
  • Wet granulation – high shear wet granulation as well as top spray fluid bed granulation
  • Coating – film coat, functional coat and wurster coating for mini tablets and beads
Syngene offers expertise in utilizing the principles of Quality by Design (QbD):
  • Risk Assessment: Conducted for formulation as well as process parameters to identify the high risk factors that could potentially impact the critical quality attributes of the product
  • Experimental Design: Used for identification and optimization of processing parameters that can affect the quality of the product

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