Comparison of Next-Generation Sequencing Systems

Use of clinical-grade human induced pluripotent stem cell (iPSC) lines as a starting material for the generation of cellular therapeutics requires demonstration of comparability of lines derived from different individuals and in different facilities This requires agreement on the critical quality attributes of such lines and the assays that should be used Working from established recommendations and guidance from the International Stem Cell Banking Initiative for human embryonic stem cell banking, and concentrating on those issues more relevant to iPSCs, a series of consensus workshops has made initial recommendations on the minimum dataset required to consider an iPSC line of clinical grade, which are outlined in this report Continued evolution of this field will likely lead to revision of these guidelines on a regular basis

Quality control guidelines for clinical-grade human induced pluripotent stem cell lines.

The discovery of induced pluripotent stem cells (iPSCs) and the concurrent development of protocols for their cell-type-specific differentiation have revolutionized our approach to cell therapy. It has now become critical to address the challenges related to the generation of iPSCs under current good manufacturing practice (cGMP) compliant conditions, including tissue sourcing, manufacturing, testing, and storage. Furthermore, regarding the technical challenges, it is very important to keep the costs of manufacturing and testing reasonable and solve logistic hurdles that permit the global distribution of these products. Here we describe our efforts to develop a process for the manufacturing of iPSC master cell banks (MCBs) under cGMPs and announce the availability of such banks.

cGMP-Manufactured Human Induced Pluripotent Stem Cells Are Available for Pre-clinical and Clinical Applications

https://dc.engconfintl.org/cgi/viewcontent.cgi?article=1075&context=cellbasedtherapies_v

Opportunities for applying biomedical production and manufacturing methods to the development of the clean meat industry

Cell-cultured meat and seafood offer a sustainable opportunity to meet the world's increasing demand for protein in a climate-changed world. A responsible, data-driven approach to assess and demonstrate safety of cell-cultured meat and seafood can support consumer acceptance and help fully realize the potential of these products. As an initial step toward a thorough demonstration of safety, this review identifies hazards that could be introduced during manufacturing, evaluates applicability of existing safety assessment approaches, and highlights research priorities that could support safe commercialization. Input was gathered from members of the cultured meat and seafood industry, researchers, regulators, and food safety experts. A series of workshops were held with 87 industry representatives and researchers to create a modular manufacturing process diagram, which served as a framework to identify potential chemical and biological hazards along the steps of the manufacturing process that could affect the safety of a final food product. Interviews and feedback on draft documents validated the process diagram and supported hazard identification and evaluation of applicable safety methods. Most hazards are not expected to be novel; therefore, safety assessment methods from a range of fields, such as conventional and novel foods, foods produced from biotechnology, pharmaceuticals, and so forth, are likely to be applicable. However, additional assessment of novel inputs or products with significant differences from existing foods may be necessary. Further research on the safety of the inputs and associated residues, potential for contamination, and development of standardized safety assessment approaches (particularly animal-free methods) is recommended.

Food safety considerations and research priorities for the cultured meat and seafood industry.

In 2009 the International Stem Cell Banking Initiative (ISCBI)
contributors and the Ethics Working Party of the International
Stem Cell Forum published a consensus on principles of best
practice for the procurement, cell banking, testing and
distribution of human embryonic stem cell (hESC) lines for
research purposes [1], which was broadly also applicable to
human induced pluripotent stem cell (hiPSC) lines. Here, we
revisit this guidance to consider what the requirements would
be for delivery of the early seed stocks of stem cell lines
intended for clinical applications. The term ‘seed stock’ is
used here to describe those cryopreserved stocks of cells
established early in the passage history of a pluripotent stem
cell line in the lab that derived the line or a stem cell bank,
hereafter called the ‘repository’.

/pdf/points-to-consider-in-the-development-of-seed-stocks-of-dn8yweezfp.pdf

Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI)

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Points to consider in the development of seed stocks of pluripotent stem cells for clinical applications: International Stem Cell Banking Initiative (ISCBI)