These include advances in tissue culture medium, extracellular matrix, 3D synthetic cell culture plastic, growth factors, dissociation enzymes, cryopreservation agents and differentiation technologies. Significant advances that overcome the challenges of the past have been made in all aspects of in vitro stem cell culture. Researchers and clinical developers benefit alike from GMP-focused innovations in stem cell technologies that deliver consistent growth properties and high-quality results. Once reserved for clinical applications, GMP has become a dominating concept that affects all aspects of stem cell research and applications. As such, in the ‘real world’ the quality and consistency of the reagents used in a stem cell manufacturing process is paramount for downstream clinical applications, even if the project is still in the R&D or preclinical phase. In simple terms, every reagent that touches the stem cells in the manufacturing process throughout the entire lifetime of the stem cell becomes a component of the final product. Unlike chemically synthesised medicines where the final product can be defined through chemical analysis, ATMPs are complex biological living entities whereby the entire manufacturing process defines the final product. The use of stem cells as therapeutic agents has necessitated specialised drug regulations known as Advanced Therapeutic Medicinal Products (ATMPs). This is governed by formal regulations administered by drug regulatory agencies (for example the FDA) that control the manufacture processes of medicines. GMP: The Future is About Process ResilienceĪn important concept affecting current and future innovations in stem cell technologies is Good Manufacturing Practice (‘GMP’). Historically, pluripotent stem cells were notoriously difficult to work with in the lab largely because of the of inherent variability of reagents derived from animal tissues. In short, if stem cells are not dividing in log phase growth, they are differentiating. Culture expansion of stem cells is tricky because they must be maintained in an undifferentiated state and not permitted to differentiate into other cell types until desired. To harness the power of stem cells, they must first be maintained in vitro tissue culture. Working with Stem Cells in Lab - Past and Present This article focuses on pluripotent stem cells, as they offer the most promising future applications. This discovery transformed our understanding of stem cell biology enabling exciting and substantial advances in stem cell tools, technologies and applications. There have been many exciting advances in stem cell biology, most notable the discovery of induced pluripotent stem cells (iPSCs) that demonstrated a mature differentiated specialised cell can be reverted to a primitive pluripotent stem cell (Takahashi K, 2006). It was long believed that stem cell differentiation into specialised cell types only occurs in one direction. epidermal stem cells that produce skin) give rise to only one cell type. mesenchymal stem cells) are able to generate multiple, but not all, specialised cell types and, iii) unipotent stem cells (e.g. embryonic stem cells) can generate any specialised cell type ii) multipotent stem cells (e.g. There are three different types of stem cell, classified by the number of specialised cell types they can produce: i) pluripotent stem cells (e.g. Stem cells are the foundation of living organisms, with the unique ability to self-renew and differentiate into specialised cell types. Every cell type in the body that makes up organs and tissues arose from a more primitive cell type called a stem cell.
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