cGMP Manufacturing

 

We offer comprehensive solution for all your cGMP manufacturing needs. Stelis have fully integrated state-of-the-art facility with end to end capabilities located in Bangalore, India. The facility has the capability to produce simple and complex recombinant biotherapeutics from microbial cell culture system. The facilities have been designed to meet the latest guidelines and expectations of regulators in developed countries (US FDA, EMA) as well as WHO and PICS. We have adopted disposable systems with single-use components and flow paths extensively for better regulatory compliance greater operational flexibility.

cGMP Manufacturing
 

DS Manufacturing

  • The 75000 sq. ft facility has dedicated suites for microbial and mammalians (coming soon...) based processes.
  • We offer conventional fermentation capability disposable single use technologies in downstream processing in microbial suite.
  • We have the capacity and scale to manufacture for both clinical (phase 1 to 3) & commercial requirements.
 
  • DS Manufacturing
  • DS Manufacturing
  • DS Manufacturing
 

Formulation, Aseptic fill   Finish

  • We have installed high end automated filling lines integrated with isolators to meet drug supply needs for clinical or commercial requirement.
  • We have the capability to convert DS into stable formulations and fill finish in all injectable formats – PFS, cartridges, vials including lyophilized formats. Our automated packaging lines come with labeler, syringe assembling systems, blistering cartoning. We have dedicated warehouses with cold chain inventory management.
Presentation Equipment Working Range Capacity/Annum*
Cartridge Bausch+Strobel filling line integrated with Steriline isolator Diameter 7mm to 14mm Height 40mm to 90mm 20 million
Pre-Filled Syringe Bausch+Strobel filling line integrated with Steriline isolator 0.5ml to 10ml 10 million
Vial Tofflon filling line integrated with isolator and Lyophilizer 1ml to 100ml 40 million
Lyophilization Attached to vial filling machine for both clinical and commercial use Commercial: 9.2 sq. m
Clinical: 5.11 sq. m
2 million

(*on single shift basis)

 
  • Formulation, Aseptic fill & Finish
  • Formulation, Aseptic fill & Finish
 

Quality Control Testing

We offer on-site cGMP analytical microbiological testing services to support in-process and release requirements. We also offer thorough characterization of reference as well finished product for complete analytical comparability requirements.

Testing Capabilities

 

  • Raw material, consumables and packaging material
  • In-process release testing
  • Analytical method validation as per ICH, US-FDA and EMA guidelines
  • Complex bioassays including cell based, immunological assays
  • Protein characterization
  • Microbiological testing and
  • Stability testing as per ICH guidelines
cGMP Manufacturing