Advanced therapy drugs that fall under the definition of Advanced Therapies Medical Products (ATMPs) are biological pharmaceuticals that cannot, by their nature, be sterilized.
For this reason, the production process should be conducted aseptically, i.e. under conditions that prevent microbial contamination.
The main risks of the aseptic production of ATMP in a clean room are due to the presence and movement of operators and to the absence of physical barriers between product and operator. If, on the other hand, production takes place in an isolator, that is, in a closed system, there may be a risk related to the transfer of materials.
The transfer of materials in and out of the isolator is a major potential source of contamination and appropriate control measures should be put in place. When materials are introduced / removed from the closed system without aseptic connection, the system can no longer be considered closed.
In order to reduce the risk of contamination, a system for the transfer of biological samples has been developed by Zanini C et al, in particular for the transfer of biological samples from an isolator in Grade A (ISO 4.8) to external standard CO2 incubators, and vice versa, without breaking the continuity of the bio-confinement.
This system allows to scale-up the production using standard external CO2 incubators in an unlimited number and allows to work with biological samples from different patients, reducing to zero the risk of cross-contamination between samples.