Comparability: manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14–15 September 2015

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 added subsequently to the workshop. Comparability is the need to demonstrate equivalence of product after a process change; a recent publication states that this ‘may be difficult for cell-based medicinal products’. Therefore a well-managed change process is required which needs access to good science and regulatory advice and developers are encouraged to seek help early. The workshop shared current thinking and best practice and allowed the definition of key research questions. The intent of this report is to summarize the key issues and the consensus reached on each of these by the expert delegates

The life cycle of regenerative medicine - FIRM Symposium 2016

The life cycle of regenerative medicine - FIRM Symposium 201

Treatment of problematic waste: a case study using wood

Waste is a complex societal problem: municipal solid waste (MSW) should be considered a resource, but the methods for capturing, treating, and utilising this resource are varied and often dependent on geopolitical factors. Previous research has, on the one hand explored the need for a more comprehensive waste composition specification in order to better manage municipal waste, and on the other focused on a problematic waste stream and the options available for dealing with it. The current work considers the use of multi-criteria decision making in order to assess the relative merits of different treatment options. A complex and problematic waste stream, wood, has been selected as a case study. For the purpose of the study, the work considers the options available to Surrey County Council in the UK. At the present time, for the conditions selected, energy from waste was considered to be the best option available for the treatment of wood with no discernible value for upcycling or reuse, but not contaminated with hazardous chemicals. When considering a different location with different circumstances, a different solution might be found

Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop

Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates