Flexible and Multi-Modal ATMP Facilities

Flexible manufacturing equipment and process flows can now support many distinct production modalities. Multimodal facilities can be designed to accommodate equipment and process flows enabling ease of changeover between entities; concurrent production of more than one product; and ease of future modifications. Distinctions in ATMP facility design are determined by the manufacturing technologies, safety requirements, and regulatory characteristics of the active substance (cell, peptide, or oligo type), delivery vector (viral, vesicle, or molecular), and drug product. Considerations in multi-modal facility design begin with such high-level questions as what in-house manufacturing will be change-over dependant (campaign based), or parallel and concurrent production based. Then such tactical questions can be entertained as the required biosafety level or hazardous area classification; closed, single-use and/or automated processes; straight through processing; and environmental sustainability imperatives. The GMP considerations relating to regulations such as EU GMP Annex 1 and PIC/s Annex 1 are also a critical factor particularly in relation to CT manufacturing. Creative solutions for multi-modal facilities are now supported by such Pharma 5.0 advances as modern building information modelling (BIM) technologies. Such digital architectural tools enable suite and facility designs optimising the desired flexibility in equipment and process flows.