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 a 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:
The development of guiding principles used to determine when and how multiple modalities may be accommodated in the same facility.
The development of a risk profile to determine how best to accommodate the different modalities based on any facility constraints that may exist.
Determining when separate facilities are required based on clear guidance within the regulations and any important boundaries that may exist.
Alf Penfold, Group GMP/Regulatory SME, PM Group
Alf has more than 30 years of client experience in the Pharma & Biotech industry. His role is focused on cGMPs & Regulatory Compliance. He is recognised internationally as a Subject Matter Expert in Serialisation having advised the FDA. Alf is a member of the ISPE Regulatory Quality Harmonisation Committee for Europe, the Middle East and Africa.
Tom Bannon, Biologics & Advanced Therapies SME, PM Group
Tom is a Process SME with over 16 years’ experience and specialises in protein therapeutics, gene therapy & cell therapy facility design.
Tom regularly speaks at conferences on his contributions to the industry and has co-authored industry best practise guides.