Computer-aided 3D printing approaches to the industrial production of customized 3D
functional living constructs for restoration of tissue and organ function face significant regulatory …

… Steven Ruck, Qasim Rafiq and Nicholas Medcalf. Diagrams and visual material … by Nicholas
Medcalf. Critical revision of the article was carried out by Qasim Rafiq and Nicholas Medcalf. …

Decentralized or “redistributed” manufacturing has the potential to revolutionize the
manufacturing approach for cell and gene therapies (CGTs), moving away from the “Fordist” …

Aim: Manufacturing methods for cell-based therapies differ markedly from those established
for noncellular pharmaceuticals and biologics. Attempts to ‘shoehorn’ these into existing …

Background The cell and gene therapy (CGT) field is at a critical juncture. Clinical successes
have underpinned the requirement for developing manufacturing capacity suited to patient-…

Introduction Local delivery of mesenchymal stem cells (MSCs) to the acutely injured or
osteoarthritic joint retards cartilage destruction. However, in the absence of assistive materials the …

Cell therapies, especially autologous therapies, pose significant challenges to researchers
who wish to move from small, probably academic, methods of manufacture to full commercial …

In this paper we assess both the ex ante and the ex post dimensions of the regulatory
landscape of 3D bioprinting governance. While the former is mainly concerned with the market …

This paper summarizes the proceedings of a workshop held at Trinity Hall, Cambridge to
discuss comparability and includes additional information and references to related information …

Flow cytometry is a complex measurement characterization technique, utilized within the
manufacture, measurement, and release of cell and gene therapy products for rapid, high-…