Sterility and Cross Contamination Challenges in Tissue Engineering and Regenerative Medicine
Waarschuwing! De inhoud van deze pagina is alleen beschikbaar in de volgende talen: Engels - French
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.
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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