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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Downstream Bioprocessing Update

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GUEST EDITOR: Michael Covington, Principal, CMC Regulatory Policy & Strategy, Juno Therapeutics As the need for rapid, robust and cost-effective downstream processing of cell & gene therapies has increased, so the sector’s enabling technology providers and their industrial and academic partners have invested and collaborated as never before to develop novel solutions, repurpose existing ones, and to seek clarity in regulatory guidelines and standards. Understanding exactly what benefits and advantages emerging options can offer – for example, automated and single-use tools – has never been more vital.
  • Product purification and polishing (of both cell-based therapies and viral vectors)
  • Fill & finish and preparation for biopreservation
  • Release testing
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