Pluristem Therapeutics Inc (PSTI)

[FDApproved]

For example, Lior Raviv, Chief Technology officer at Israeli-based biotech Pluri, told delegates while the process directly affects the product and changes in manufacturing will, of course, change the product, his company is taking an ‘engineering-by-design’ approach to its allogeneic stem cell candidates “to change the art of growing cells into an industrialized process.”

He said: “We build a black box about every step of the operation to truly learn what are the inputs and what are the outputs, and how they are connected to the critical quality attributes.”

https://bioprocessintl.com/bioprocess-insider/therapeutic-class/cgt-myth-busting-the-process-is-not-the-product/#:~:text=CGT%20myth%2Dbusting%3A%20%27The%20process%20is%20NOT%20the%20product%27&text=This%20was%20the%20opinion%20of,mechanisms%20used%20to%20produce%20it.