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.
