Abstract
Quality control (QC) and quality assurance (QA) are fundamentally important for commercial manufacture of medicines, particularly so for delivery of cells for therapy. Continued assessment of cell product quality throughout the manufacturing process, either directly or by developing highly defined processes that meet stringent QA standards, is essential to ensure that the products are of a high quality and that high reproducibility between batches is achievable. This chapter addresses some of the issues that have to be considered for ensuring that cell products delivered to the patient are safe and effective. Crucially, considerations for the safety, purity, identity and potency of the cells are discussed.
Original language | English |
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Title of host publication | Standardisation in Cell and Tissue Engineering |
Subtitle of host publication | Methods and Protocols |
Publisher | Elsevier |
Pages | 148-165 |
Number of pages | 18 |
ISBN (Print) | 9780857094193 |
DOIs | |
Publication status | Published - 1 Jan 2013 |
Keywords
- Autologous
- Biomanufacturing
- Bioprocessing
- Cell therapy manufacture
- Commercialisation
- Critical quality attributes
- Process development
- Quality assurance
- Quality control
- Tissue engineering
- Translation