cGMP Manufacturing

 

The Stelis manufacturing facility (scheduled completion - end of 2018) is designed by reputed international consultants to meet global cGMP standards.
It will be one of the upcoming facilities in the Asia Pacific region with end-to-end capabilities in DS & DP manufacturing, all integrated in one facility. The facility will cater to the needs of both clinical and commercial supply requirements of recombinant peptides and proteins including antibodies.

cGMP manufacturing
 

Ds Manufacturing - Upstream

  • MICROBIAL

  • Stainless steel fermenters (Sartorius) of capacity 50L, 300L & 1000L
  • Homogenizer (GEA) and centrifuge (GEA) well integrated with fermenter for quick product isolation
  • Dedicated pre-culture area
  • Dedicated autoclaves for sterilization and decontamination
  • CELL CULTURE

  • 4 Single-use bioreactor trains up to 2000L (Merck Millipore)
  • Capable of handling batch, fed batch & perfusion fermentation
  • Production, testing and storage of master and working cell banks
  • Dedicated pre-culture suites, media and buffer preparation rooms
 
  • Ds Manufacturing - Upstream
  • Ds Manufacturing - Upstream
 

Ds Manufacturing - Downstream

  • MICROBIAL

  • Flame proof area with High Pressure chromatography system
  • Single-use chromatography systems with capability to perform ion exchange, affinity, hydrophobic interaction, size exclusion chromatography
  • Filtration: Viral filtration, ultrafiltration and diafiltration, hollow fibre filtration
  • Dedicated area for conjugation, bulk filtration and lyophilization
  • CELL CULTURE

  • Pre - and post - viral segregation
  • Single-use chromatography systems with capability to perform ion exchange, affinity, hydrophobic interaction, size exclusion chromatography
  • Filtration: Viral filtration, ultrafiltration and diafiltration, hollow fibre filtration-in depth and cross flow modes
  • Dedicated autoclaves for sterilization and decontamination
  • Controlled freeze and thaw system
 
  • Ds Manufacturing - Downstream
  • Ds Manufacturing - Downstream
  • Ds Manufacturing - Downstream
 

Fill, Finish & Packaging

  • FILL FINISH

  • Freeze & Thaw systems
  • Aseptic liquid filling in all formats:
    • PFS (12000/h) [Bausch Strobel]
    • Cartridges (12000/h) [Bausch Strobel]
    • Vials under isolator (9000/h) [Tofflon]
  • Lyophilization in vials with automatic loading/ unloading systems and capping machine
  • 100 % Visual Inspection, Leak Testing machines
  • Cold rooms for storage of product at various stages
  • PACKAGING

  • Pre and post viral segregation
  • Fully automatic packaging line with labeler, syringe assembling systems, blistering and cartoning machines
  • Tertiary packaging area
  • Track and trace systems
  • High capacity warehouse with cold chain inventory management
 
  • Fill, Finish & Packaging
  • Fill, Finish & Packaging
  • Fill, Finish & Packaging
cGMP manufacturing