Fact Sheets

North Bangalore Facility, India


Integrated state-of-the-art manufacturing facility for development and commercial manufacturing of biologics and biosimilars in multiple fill finish formats. 

As a CDMO partner for the global biopharmaceutical industry, Stelis is committed in helping you achieve your project goals and timelines by enabling to accelerate development and commercialization of biologics for unmet patient needs, mutually benefiting in the growth trajectory. Our highly automated cGMP compliant facilities offer
process development through clinical and commercial manufacturing, at various flexible scales to fit individual client and product requirements. 

With deep technical expertise and capabilities coupled with marquee partnerships, Stelis has developed biologics for diabetes, osteoporosis and hemorrhoids using mammalian and/or microbial systems from pre-clinical stage through commercialization. We remain a preferred choice for our clients because we offer customized services according to their requirement in size, scale, design, and business model.

We embrace quality at every step of integrated process development and manufacturing.

Our North Bangalore facility is designed to support the entire product lifecycle of various drug substances and drug products ensuring compliance with the strict pharmaceutical regulations required for cGMP compliance. Our Quality Management System is modelled around US FDA 6-Systems and our expert and functionally independent quality team guarantees compliance with ICH Guidance, Indian Regulations, EU GMP Guidance, US FDA Guidance, Health Canada, Anvisa and Current Industry Standards.

Manufacturing Capacity Drug Substance Microbial Facility

  • Stainless steel fermenters (Sartorius) of capacity 50L, 300L & 1000L
  • 1X5000L stainless steel fermenter 
  • 1X1000L stainless steel fermenter
  • Homogenizer (GEA) and centrifuge (GEA) integrated with fermenters
  • Capable of handling bacterial and yeast strains
  • Flame proof area with high pressure chromatography system (Hanbon)
  • Filtration: viral filtration, ultrafiltration and dia-filtration
  •  Dedicated area for conjugation, bulk filtration & lyophilization

Mammalian Facility

  • 4 single-use trains up to 2000L
  • 52000L bioreactor capacity with 26 bioreactors
  • Capability of handling batch, fed batch and perfusion cell culture process
  • Single use bags-based drug substance manufacture
  • Dedicated pre-culture suites, media & buffer preparation rooms
  • Controlled freeze and thaw system
  • Production, testing and storage of master and working cell banks
  • Filtration: viral filtration, ultrafiltration and dia-filtration

Drug Product

  • Formulation operations for 50,100 & 200l using Praj Hi-purity systems
  • Tofflon filling line integrated with isolator and Lyophilizer
  • High speed vial line attached to vial filling machine
  • Bausch Strobel filling line integrated with steriline isolator
  • 2 Boilers of capacity 3000 kg/Hr and one of 5000kg/Hr
  • Cooling tower with capacity 180 TR and 4 HVAC chillers of capacity 180 TR
  • Secondary packaging operations at a capacity of 100 cartons/ min
  • High-capacity warehouse with cold chain inventory management

Quality Control

  • On-site analytical and microbiology labs to support in-process and release testing
  • Comprehensive monitoring of all in-process product quality parameters drug substance and drug product release testing.
  • Usage of fully automatic packaging line and 100% visual inspection of the entire process.
  • Routine In facility contamination controls by utilities testing and environmental monitoring activities by active air sampling, passive monitoring by settle plate and by surface monitoring for classified areas and inbuilt active air samplers within Isolators in line with regulatory requirements. Environment isolates and organisms recovered from investigational samples were identified up to species level

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