Mark W Lowdell & Owen Bain
Supply Chain Management: PoC considerations, Product Tracking & Data Management
Advanced therapy medicinal products (ATMPs) are, without doubt, the most complex medicines being developed and they come with some unique supply chain problems which are often under-estimated or completely misunderstood. The sheer diversity of ATMPs from relatively simple suspensions of somatic cells for immunotherapy or regenerative medicine to complex combination products of cells on medical device scaffolds prevents a comprehensive analysis of supply chain problems but there are very many issues which are universally important or, at least, common to the majority of ATMPs. Similarly, the regulation of cell and tissue therapies differs across the World and critical considerations in one regulatory domain are sometimes irrelevant in others. The term ATMP is unique to the European Union and incorporates all of the cell, gene and tissue therapies which are being developed. However, there are important distinctions across the World where, for example, a combinatorial ATMP consisting of cells applied to a medical device in the EU is not regulated as a medicine in the USA but remains a medical device. This article will focus on the EU ATMP situation but will comment on how the same issues are dealt with in other jurisdictions.
Submitted for review: Oct 20 2017 Published: Dec 15 2017
Citation: Cell Gene Therapy Insights 2017; 3(10), 843-851.