cell therapy

Close-up of a scientist's hand, wearing a purple glove, using tweezers to handle a small transparent container filled with a pink liquid. The container is being placed into a tray that holds several other similar containers, all filled with the same pink liquid. This scene is likely taking place in a controlled laboratory environment, indicating precision and care in scientific research or experimentation, possibly involving cell cultures or chemical analysis.
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Keys to Success: Allogeneic Cell Therapy Manufacturing

Robust commercial scale bioprocessing workflows must be established along with strategies for sterility assurance during the production of allogeneic products.
Bioprocessing considerations include:
• Establishing a robust process
• Ensuring process compatibility
• Creating the sampling plan
• Planning for media production

Sterility assurance considerations include:
• Using GMP materials
• Qualifying raw materials
• Adopting closed processing
• Performing aseptic process simulations
• Ensuring proper sterile filtration
• Understanding extractables, leachables, and particulates

by Amandine Biehler August 27, 2024

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