By: Robert Shaw
CEll CUltUrE
Industrializing the Production
oF STeM ceLLS
Stem cells have the potential to yield a readily available, consistent source of many differentiated cell types. This unique property can be leveraged for therapeutic purposes and for facilitating and improving a number of drug discovery and development processes such as toxicity screening (Figure 1). Large-scale “industrialized” production of stem cells is necessary to enable their advancement into human clinical trials and to effectively deliver the quantities needed for drug discovery screening and lead optimization. However, achieving this level of production while meeting rigorous quality standards will depend on further progress in the areas of cell culture and scale-up, characterization, enrichment and purification to deliver a consistent and reproducible supply of cells.
Large-scale cGMP Production of Stem Cells Advancement of stem cell-based therapeutics into clinical trials requires well-characterized cells produced under tightly controlled, consistent, reproducible culture conditions that adhere to Current Good Manufacturing Practice (cGMP) standards (Figure 2). cGMP standards, established by the FDA, cover the manufacture and testing of pharmaceutical products and dictate that processes are clearly defined, validated, and controlled to ensure consistency and compliance with specifications. cGMP stem cell culture systems will need well-defined, optimized media and supplements to support stem cell expansion and differentiation. The use of efficient, standardized methods Figure 1: Large-scale production of stem cells is necessary to support development of therapeutic applications and drug discovery and development applications.
MAY 2012 BIOTECHNOLOGY FOCUS 19
