GeneFab – Your ready-to-configure ATMP-facility

Expanding the production of ATMPs to serve more patients brings several challenges. Besides the fact that every manufacturing facility must accommodate patient-specific production, there are other challenges like the requirement of QC release testing and the establishment of a chain of custody for transferring individual doses. Since cell-based products have short self-lives, there may be no delays or congestion during the process. External conditions of the production and testing process should also be determined. By defining the starting materials and raw materials in advance, critical material attributes and critical quality attributes (CQAs) can be established to fulfil requirements of the quality by design methodology.

The amount of equipment necessary to produce commercial volumes of ATMPs is generally high. It is crucial to design an efficient room layout so as not to create an oversized space that is costly to condition and operate due simply to the volume of the space. Conversely, undersizing the space results in cramped working conditions. Advanced Therapy Medicinal Product production are often carried-out within Grade A biosafety cabinets with a Grade B background or within isolators. These pieces of equipment also occupy a relatively large footprint within the production suite. It is important to provide proper operating clearances while also accommodating the flow of materials and operators through the production suite in a way that will not adversely affect the use of the equipment or the quality of the environment.