Challenges in the procurement of starting materials for ATMP manufacture

Somatic cell, genetically modified and tissue engineered advanced therapies share a common generic supply chain with other substances of human origin such as blood components, tissues, minimally manipulated cells and solid organs. The quality, safety and efficacy of the medicinal product at the point of administration to the patient is contingent on the entirety of its provenance including the selection and screening of the donor, procurement and distribution of the starting material, manufacturing, and return to, and management within, the healthcare environment. Information, chain of identity and regulatory compliance must flow bi-directionally, often across several different organizational boundaries. Moreover, the heterogeneity of advanced therapies is accompanied by considerable diversity in supply chains and complexity and disruption to existing modes of operation which act as a barrier to adoption. Overcoming these challenges and realizing the benefits of this new generation of therapies requires a new philosophy of long-term collaboration, mutual understanding and partnership between commercial and healthcare organizations.

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