How to Accommodate Multiple Modalities in the Same Facility - Including Cell and Gene Therapies

ATMP (Advanced Therapy Medicinal Products) facilities are different to the more conventional pharmaceutical facilities, often requiring heightened segregation whilst complying to Annex 1. Many organisations are evaluating how different modalities may be combined within the same facility having acquired a building, or having constructed an agnostic building. Accommodating multiple modalities in the same facility is therefore becoming an increasingly important requirement and not least during the COVID-19 pandemic when rapidly developing and launching new vaccines. The presentation describes a basic framework and methodology that may be used when evaluating different types of modalities and how they may be accommodated in a new or existing facility. A case study is used to demonstrate how the approach may be applied to an existing facility as follows: 1) The development of guiding principles used to determine when and how multiple modalities may be accommodated in the same facility. 2) The development of a risk profile to determine how best to accommodate the different modalities based on any facility constraints that may exist. 3) Determining when separate facilities are required based on clear guidance within the regulations and any important boundaries that may exist. The guiding principles and risk profile are developed with reference to the applicable regulations, including Annex 1, when determining which modalities may be accommodated in the same facility.