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.
|