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R&D for Process Development

The initial stages of R&D are conducted in separate laboratories equipped with small fermentors and a variety of equipment to cover all aspects of analysis, cell culture, fermentation and product purification.

Among the stages:

  • Small scale R&D of cell culture and microbial​ fermentation processes.
  • Assay development for quality control/ in-process control testing and product release
  • Development of downstream production processes
  • Product characterization

cGMP Manufacturing

  • Master-stock preparatio​n and cell banking
  • Production of cell-culture-derived biologicals
  • Fermentation and production of microb​ial-derived biologicals
  • Purification / product formulation / fill and finish
  • Material handling, tracking and storage / cGMP compliance auditing / validated systems
  • Full quality control monitoring of all stages
  • Quality assurance release and document preparation​

Range of Products Produced at IIBR: 

  • Monoclonal antibodies and antigens from cell cultures
  • Recombinant enzymes from animal cells
  • Subunit vaccines
  • Human and veterinary recombinant lymphokines
  • Viral vaccines
  • Recombinant proteins from bacterial/fungal fermentations​

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