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We offer comprehensive solutions 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 has WHO and PICS. We have adopted disposable systems and single-use components and flow paths extensively for better regulatory compliance greater operational flexibility.

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.

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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 labeller, syringe assembling systems, blistering cartoning. We have dedicated warehouses with cold chain inventory management.

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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

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