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Comprehensive Mammalian Biologics CDMO

  • From mammalian Cell line development to cGMP commercial manufacturing we will be at your service to deliver qualitative and cost effective mAbs.
  • We mitigate your cost of burden by offering both Drug Substance and Drug Product of mAbs for clinical trails and commercial production without any compromise in Quality
  • Our diversified technology platforms, customizable solutions, state-of-the-art infrastructure will amplify your clinical and commercial success for mAbs.
  • We work purely on a contract basis protecting the intellectual property of the clients at any or all stages of biologics development
  • We enforce strict adherence to regulations required for cGMP biopharmaceutical drug substance and drug product manufacturing.

CELL LINE DEVELOPMENT

  • Gene synthesis
  • Transfection
  • Clone screening and selection
  • Stable pool generation
  • Single-cell isolation and cell viability
  • Clone productivity screening
  • Primary Cell Bank Generation
  • Mono-clonality assurance
  • Cell line stability studies

PROCESS DEVELOPMENT

  • Upstream and Downstream Process Development
  • Media and cell culture optimization
  • Identification of Critical and Key Process parameters
  • Analytical methods to identify CQA’s
  • Head to head comparability studies
  • DS and DP stability studies

DS MANUFACTURING

  • cGMP manufacturing in compliance with global regulatory guidelines
  • cGMP Mammalian cell banking
  • cGMP Mammalian manufacturing up to 2KL
  • Clinical & commercial manufacturing
  • Single use bioreactor systems

 ASEPTIC FILL FINISH

  • 3 in 1 combo filling line
  • Liquid fill vials catering the range of 3 ml, 20ml, 50ml
  • Lyophilized vials filling unit with a shelf area of 70 sq.ft
  • Prefill syringes featuring a capacity of 0.5ml

Contact us to find out more

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