International Standards for publication of Stem Cell Research

Section 1 of the ISSCR Standards provides advice on the basic principles of stem cell culture including information on acquisition/generation, preservation and early characterization which is essential to promote reproducibility and safety in the laboratory.

One of the most important factors to consider for laboratory quality control and safety is Cell Hygiene. Cell cultures should undergo microbiological and viral testing including routine mycoplasma screening to promote sterility.

The recommended testing frequency from the ISSCR Standards is for initial screening of cultures upon entering the laboratory, to be followed by regular monitoring (quarterly at a minimum). A particularly important time-point is when sharing lines outside the laboratory, to prevent the spread of contamination between research laboratories.

When acquiring new cell material (whether this be donor samples, primary tissues, or cell lines) appropriate transfer agreements are essential to provide background on all associated donor and supplier/provider restrictions. It is essential that researchers understand these restrictions and agreements as well as any additional local restrictions relating to the use of the materials.

Our extensive biorepository houses a wide variety of fresh tissues, which are ethically sourced and IRB-approved, and a range of cell lines. We have strict quality control measures in place and our experts are on hand to sort out all required transfer agreements to make sure you can trust your starting source.

Once cell materials have been acquired, a Master Cell Bank should be generated from the earliest possible passage of an established cell line or development of a non-adherent culture before experimental use. This is a critical process for preserving quality-controlled cells. From this master bank it is strongly recommended to make a further working cell bank for experimental use. We provide a range of trusted and validated cryopreservation solutions for cells and tissues for long-term storage with high cell viability after freeze-thaw procedures. To find out more, you can browse our CELLBANKER® cell freezing media range. It’s important to establish the nomenclature/ unique identifier for each cell line to ensure it is persistent between laboratories and can be referenced in publications.  More information is provided within the report for guidance on assigning cell line identifiers. After post-thaw, cells must be fully characterized and go through cell line authentication (Short Tandem Repeat analysis is recommended).

An important factor to consider when forming new human induced pluripotent stem cell lines is the verification of the elimination of the transgene expression prior to biobanking and experimental use.

We offer a range of viral delivery systems that can be used to overexpress reprogramming factors. qPCR can be used to confirm vector clearance, ensuring clearance of transgene expression after reprogramming. Our PCR reagents and products are available to help you source materials for qPCR validation.

Another important factor to consider is selecting cell culture conditions that support high rates of expansion while maintaining genetic stability.  Chemically defined culture conditions provide a precisely controlled and reproducible environment for cell growth and maintenance. Animal-origin free media, such as StemFit, uses well-defined and purified components, eliminating variability and batch-to-batch inconsistencies. This standardization not only enhances the reproducibility of experiments but also minimizes the risk of introducing unwanted variables that could impact the genetic stability and differentiation potential of iPSCs. Additionally, single cell expansion is becoming a popular method for producing consistent iPSC cultures. iMatrix-511 laminin E8 fragments facilitates single-cell expansion by providing extracellular matrix (ECM) support, promoting cell survival through fast attachment of cells and appropriate migration.

At AMSBIO we offer stem cell culture media, matrix and cryopreservation solutions optimized to expand a uniform set of iPSCs and maintaining genetic stability. To find out more about what we can offer visit our expanded stem cell synergy webpage or read our expert blog Culture Techniques for Expanding a Uniform Set of iPSC for Drug Discovery and Therapeutic Use | AMSBIO.

In summary, we’ve explored the critical aspects in section 1-3 of the ISSCR standards for human stem cell use in research, covering essential topics such as basic characterization, pluripotency and the undifferentiated state, as well as genomic characterization. These foundational areas are crucial for ensuring the integrity and reliability of stem cell research.

In an upcoming blog, we’ll delve into the final sections of the ISSCR standards, focusing on stem cell-based model systems and the importance of accurate and transparent reporting in research. Stay tuned for insights into how these standards guide in the publication of ethical and reliable practices in stem cell research.

For further information, including information on standards for stem cell-based model systems and experimental reporting, see our resource centre below.

Standards Document — International Society for Stem Cell Research (isscr.org)

ISSCR_Standards_Dec23_Update.pdf (squarespace.com)

ISSCR_Standards_Checklist_2024Update.pdf (squarespace.com)