
The cell & gene industry is growing at a staggering 30% CAGR and is estimated to reach US$ 14bn by 2025. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMOs/CMOs) to produce them with adherence to the stringent regulatory cGMP conditions.
Cell & gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of the batch disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for the critically ill patients.
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