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Cell Culture Scale-Up

Biotechnology scale up of animal cell culture processes for non-GMP production and process development has grown and developed as a business operation for ECACC. Key to this development has been the collaborative interaction between ECACC�s developmental scientist and the wealth of experts based at the Health Protection Agency, Proton Down.

Facilities
ECACC offers the capacity to support technology transfer and process development in a variety of systems and non-GMP production up to 100L scale. ECACC's scale-up and cell culture solutions capability offers:

  • Dedicated animal cell bioreactor facility up to ACDP class 2 containment.
  • Pilot scale (1-100L ) stirred tank
  • Roller bottle capacity to 200 roller bottles.
  • Fixed Bed bioreactor (New Brunswick Celligen) producing in excess of 100L of secreted product per run
  • 100L stirred tank bioreactor for process development and production of suspension cells
  • Metabolite analysis
  • Tangential flow filtration (TFF) for product clarification and concentration

Capabilities
ECACC�s flexible approach and industry knowledge of novel technologies has been a vital prerequisite for numerous commercial and research organisations that extensively used this service. The work conducted is tracked by a barcode driven laboratory management system (LIMS). Scale-up capabilities provided by covered at ECACC include:

  • Non GMP recombinant animal cell line glycoprotein production and process scale up
  • Baculovirus expression systems production and scale-up
  • Adenovirus expression systems system production and scale-up
  • Monoclonal antibody production and scale up using roller bottle, stirred tank and/or fixed bed perfusion system
  • Product purification
  • Product characterisation by molecular, biochemical and analytical techniques
  • 1ml-100L scale process feasibility testing and technology transfer
  • Metabolite analysis (glucose/lactate, ammonium/glutamine)
  • Up to 100L Scale-up
  • Production of cell pellets from EBV lymphoblastoid cell lines for Genomics studies
  • DNA extraction from cell pellet.

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