cGMP Manufacturing

 

We offer comprehensive solution for all your cGMP manufacturing needs. Stelis’ fully integrated, end-to-end facility in Bangalore is expected to come on stream by end of 2018. The facility has the capability to produce simple and complex recombinant biotherapeutics from both microbial & mammalian cell culture systems. The facilities have been designed to meet the latest guidelines and expectations of regulators in developed countries (US FDA, EMA) as well as WHO, 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 & cell culture based processes.
  • We offer end-to-end disposable single use technologies in cell culture operation.
  • 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 Production Capacity / Annum* Starting by
Cartridge Filling Bausch+Strobel filling line integrated with Steriline isolator Diameter 7mm to 14mm Height 40mm to 90mm 20 million Q4-2018
Pre-Filled Syringe Filling Bausch+Strobel filling line integrated with Steriline isolator 0.5ml to 10ml 10 million Q4-2018
Vial Tofflon filling line integrated with isolator and Lyophilizer 1ml to 100ml 10 million H2 - 2019
Lyophilization Attached to vial filling machine for both clinical and commercial use Commercial: 9.2 sq. m
Clinical: 5.11 sq. m
2 million H2 - 2019

(*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 qualification & validation using ICH, US FDA guidelines
  •  

  • Complex bioassays including cell based, immunological assays
  • Protein characterization
  • Microbiological testing and
  • Stability testing as per ICH guidelines
cGMP Manufacturing