Regenerative medicine as a disruptive technology: implications for manufacturing & clinical adoption

Abstract

Although regenerative medicine has been described as a disruptive innovation, there has been little critical enquiry into the nature and location of the disruption. This paper, based on ten cases in the UK, analyses the nature of disruption for allogeneic and autologous therapies in terms of manufacturing, distribution and adoption in clinical settings. We discuss the challenges of dealing with inherent variability in living systems and how this necessitates co-evolution of technologies and innovations. We propose that understanding of the distinction between disruptive and incremental innovation, and of the nature, extent and location of the disruption across sectoral value chains, can help to guide company innovation strategies and government innovation support policies for regenerative medicine, as already proposed for industrial biotechnology.

Headway and the remaining hurdles of mesenchymal stem cells therapy for bronchopulmonary dysplasia

“…The acquisition of raw materials for stem cell therapies is a complex process requiring aseptic processing protocols. Moreover, their mechanism within the body differs from medicinal drugs which makes the pharmacokinetics and pharmacodynamics challenging 120 . To market stem cells as an ‘off‐the‐shelf’ medication for BPD, easily accessible in large bulks, large‐scale manufacturing is a definite process.…”

“…To market stem cells as an ‘off‐the‐shelf’ medication for BPD, easily accessible in large bulks, large‐scale manufacturing is a definite process. This whole process of scaling up involves a long and straining cycle from the collection, storage, process and cryopreservation of stem cells to the subjection of stem cells for further improvisation, formulating it to be suitable in accordance with the targeted therapies 120 . Through analysis of suppliers and their rate of purity and sterilization techniques, high quality raw materials required for an uninterrupted and licensed medicinal product for advanced clinical trials can be secured following the success of early clinical phases.…”

“…Moreover, their mechanism within the body differs from medicinal drugs which makes the pharmacokinetics and pharmacodynamics challenging. 120 To market stem cells as an ‘off‐the‐shelf’ medication for BPD, easily accessible in large bulks, large‐scale manufacturing is a definite process. This whole process of scaling up involves a long and straining cycle from the collection, storage, process and cryopreservation of stem cells to the subjection of stem cells for further improvisation, formulating it to be suitable in accordance with the targeted therapies.…”

“…This whole process of scaling up involves a long and straining cycle from the collection, storage, process and cryopreservation of stem cells to the subjection of stem cells for further improvisation, formulating it to be suitable in accordance with the targeted therapies. 120 Through analysis of suppliers and their rate of purity and sterilization techniques, high quality raw materials required for an uninterrupted and licensed medicinal product for advanced clinical trials can be secured following the success of early clinical phases. Moreover, to prevent contamination, raw materials can be aliquoted into desired vials and packaged immediately at the supplier firm.…”