Quality control in cell and tissue engineering

I. B. Wall*, N. Davie

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

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 languageEnglish
Title of host publicationStandardisation in Cell and Tissue Engineering
Subtitle of host publicationMethods and Protocols
PublisherElsevier
Pages148-165
Number of pages18
ISBN (Print)9780857094193
DOIs
Publication statusPublished - 1 Jan 2013

Keywords

  • Autologous
  • Biomanufacturing
  • Bioprocessing
  • Cell therapy manufacture
  • Commercialisation
  • Critical quality attributes
  • Process development
  • Quality assurance
  • Quality control
  • Tissue engineering
  • Translation

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