Process Scale Up

 

Occupying an area of 7,000 sq. ft in our R&D facility, the process scale up lab offers process optimization at pilot scale for seamless transfer to manufacturing.

This is a GMP facility capable of handling BSL-2 level microorganisms and mammalian cell culture based processes. The lab has been set up in technical collaboration with Merck Life Science on single use technologies. The facility also offers Fill & Finish capabilities for pre-clinical & phase I studies in all injectable formats.

Process Scale Up
 

Upstream - Process Scale Up

  • Microbial upstream

  • Process scale up at 50L scale (SS fermenter)
  • Continuous centrifugation using disk stack centrifuge up to 150 LPH & 20,000 g force
  • Cell lysis operation with high pressure homogenizer (two stage) of 35 LPH and 1200 bar
  • cGMP cell bank preparation (MCB,WCB) + Characterization
  • Mammalian upstream

  • Process scale up at 50 & 200 L single-use Bioreactors
  • Cell separation through depth filtration unit (5 Sq. m)
 
  • Upstream Process Scale Up
  • Upstream Process Scale Up
  • Upstream Process Scale Up

Downstream - Process Scale Up

  • Low (up to 10 LPM) & high pressure chromatography (1 LPM) systems
  • Low pressure columns up to 200 mm & 150 mm high pressure columns
  • TFF systems up to 2.5 Sq. m area
  • Refolding capacity up to 200 L
  • Dedicated sterile filtration area for liquid drug substances
 
  • Downstream Process Scale Up
  • Downstream Process Scale Up
  • Downstream Process Scale Up

Formulation, Fill & Finish

  • Compounding & Formulation vessels up to 200L capacity
  • Completely automated Combi filling machine with glove box for filling all injectable formats:
    •  
    • PFS & cartridges (up to1000/hour)
    • Vials (2000/hour)
 
  • Formulation, Fill & Finish
  • Formulation, Fill & Finish
Process Scale Up