For all medicinal products, including Advanced Therapy Medicinal Products (ATMPs), it is necessary to carry out Quality Controls (QC) to ensure the quality of the medicine before it is administered to patients. In addition, during the manufacture of the ATMP, it is necessary to perform In-Process Controls (IPC), in order to know the next step that must be taken in its production. These controls (IPC and QC) must be carried out in both open and closed manufacturing processes. These two types of processes differ in the way the control is performed and in many cases even in how the control is carried out. Processes with highly automated equipment can be a very interesting option, especially for IPC, where a number of sensors are integrated so that the equipment itself performs the control and provides you with the result, without the need for an operator to take a sample or perform the analysis to provide the result in real time. Unfortunately, the controls that can be carried out in this way are still limited in the case of ATMPs and it is a very interesting field of exploration for scaling production processes, reducing production time and lowering costs.

During this presentation we will analyse the ATMP regulation for ATMPs and review the different quality controls to be performed when using open systems compared to those needed when using a closed system.