White papers

PROGRESS TOWARD COMMERCIAL SCALE AND EFFICIENCY IN CELL THERAPY BIOPROCESSING

 

Cell and gene therapy is an extremely promising and growing medical technology sector with 631 ongoing clinical trials at the end of 2015. It is applicable to oncology, cardiovascular disease, infectious diseases and other diseases. The merit of cell and gene therapy has been demonstrated by FDA approvals, however commercialisation can prove a high hurdle that can trip up even approved therapeutics such as Dendreon’s Provenge autologous cell therapy. There are however steps that can be taken to reduce the risk associated with commercialisation that companies with a cell and gene therapy portfolio should consider. This whitepaper discusses practical measures to improve the chances of commercial success:

  • Characterization and Comparability Risk reduction through Quality by Design (QbD)
  • Improving efficiency and reducing costs in development and production
  • Novel analytical technologies and methodologies
  • Ensuring successful process scale up and transfer
  • Progress towards the industrialization of cell and gene therapies through modularisation

 

Available in the October 2016 Supplement of BioProcess International:

http://www.bioprocessintl.com/manufacturing/cell-therapies/manufacturing-cell-therapies-commercial-scale-efficiency/

 

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