Abstract
The commercial manufacture of cell-based therapies is expected to revolutionise healthcare provision over the coming decades and address growing clinical needs of an aging population and associated age-related degenerative disorders. Exciting advances in the emerging field of stem cell biology have great potential to treat many of these diseases. This chapter provides an overview of the challenges of moving from a laboratory-scale experiment to regulatorily sound industrial manufacturing platforms. The adoption of standardised protocols to attain a clearly defined, high-quality product across multiple batches is essential, as is the capacity for scale-up processing for allogeneic cell therapy or scale-out processing for autologous therapy.
| Original language | English |
|---|---|
| Title of host publication | Standardisation in Cell and Tissue Engineering |
| Subtitle of host publication | Methods and Protocols |
| Publisher | Elsevier |
| Pages | 212-239 |
| Number of pages | 28 |
| ISBN (Print) | 9780857094193 |
| DOIs | |
| Publication status | Published - 1 Jan 2013 |
Keywords
- Bottlenecks
- Cell therapy
- Clinical trials
- Commercialisation
- Manufacturing
- Platform process
- Regenerative medicine
- Scale-up