Regenerative Medicine today is in wide expansion. With increasing research efforts in this field, commercial manufacturing aspects for bio-product are getting more attention.
From a GMP perspective, the most critical challenge due to specific factors characterizing cell manipulation is the asepsis of the process.
This paper also highlights other critical factors in the process to present a complete view of the risks connected with this activity.
A possible solution to these challenges is Isolation Technology, commonly used in the pharmaceutical industry and suggested by the regulatory guidelines in the field.