Cell and gene therapy flips life sciences manufacturing on its head Sponsored by Cognizant
The best way to describe the growth of cell and gene therapy is Even today, 900 companies are currently pursuing therapies, and there are more than 1,000 active clinical trials. These numbers tell us that, while CGT won’t be overtaking established biotechnologies like monoclonal antibodies, immunoglobulins or Messenger RNA vaccines anytime soon, it is quite likely to emerge as a meaningful industry subsector in the very near future.
One life sciences manufacturer told us that, while it is looking to scale up manufacturing systems for its vaccines and other traditional therapies, it is simultaneously exploring how to scale down those very same systems to better produce cell and gene therapies. This includes the equipment, the automation, the process steps, the data collection and the quality gathering systems.
This near-patient model introduces significant new requirements for life sciences manufacturers, including: require higher than normal aseptic handling procedures and transportation protocols, including cold-storage controls., including any related to tamper-proofing and identity safeguards. Samples could move through a number of third parties, collaborating on cloud-based, multi-tenanted systems.
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