Compliance Framework for Precision Therapies

Precision therapies, such as Advanced Therapy Medicinal Products (ATMPs) including cell and gene therapies (CGTs), radioisotopes being radioligands, and human organs and tissues, present unparalleled supply chain challenges due to extreme sensitivity, short viability windows, identity/custody needs, and stringent regulatory requirements. Traditional pharmaceutical supply chains are not fully equipped to meet these needs at scale. Recent literature on CGT logistics emphasises for example needle-to-needle traceability and ultra-cold chain needs, with logistics forming a core part of therapy delivery integrity.

Pharma.Aero initiated this project to explore the potential needs and predefine compliance framework criteria for the logistics and handling of precision therapies. The project will review current certifications and industry standards existing for standard pharmaceuticals, identify gaps, and assess whether existing frameworks can be adapted or if a new, dedicated certification programme or industry standards are needed.

Findings will be shared with regulatory and advisory bodies to ensure safety, compliance, and quality across the precision therapies supply chain.