The International Society for Stem Cell Research (ISSCR) recently published an updated standards document, laying out 5 focus areas for stem cell researchers. With a focus on quality, consistency and standardization, the document will be an invaluable source of guidance for human stem cell researchers to ultimately drive better quality cell models for research and drug discovery. In this article, we outline the main areas for discussion, look at how the document may impact research in the iPSC industry, and present our Compliance Statement in accordance with the guidance.
Driving quality and consistency for in vitro drug discovery
If iPSC technologies are to reach their enormous potential in drug discovery, we need to prioritize quality.
This has always been our approach, and investing in an industry-leading quality management system has enabled us to conduct high-quality research, collaborate with leading Biopharma companies and drive the conversation around human iPSCs and disease modeling.
Naturally, we welcome the release of the ISSCR standards document; it provides a firm, definitive stake in the ground to human stem cell researchers. In essence, it lays out minimum standards to ensure stem cell research is planned, conducted and reported in a consistent, robust manner.
The 5-step approach to quality stem cell research
The document lays out core principles and working practices across 5 key areas.
- Basic characterization: Standards for the consistent generation and characterization of materials- particularly starting materials.
- Pluripotency and the undifferentiated state: Guidance on pluripotency assessment and clarification of terminology
- Genomic characterization: Best practices for assessing culture-acquired genetic changes, which can hamper reproducibility
- Stem cell-based model systems: Standards for maximizing the rigor, reproducibility and validity of complex stem cell models (organoid and organ-on-a-chip models)
- Reporting: Guidelines for minimum reporting standards in scientific publications, including a useful checklist
You can read the full standards document here: Standards Document — International Society for Stem Cell Research (isscr.org)
What does this mean for human stem cell research?
With the FDA Modernization Act 2.0 sparking industry-wide interest in human stem cell models, the ISSCR standards document arrived at the opportune moment.
We believe that setting these minimum standards will raise the quality of human stem cell research, placing high-quality data acquisition and reporting at the forefront of the industry. This is especially important given the variation in protocols, starting material and quality management systems between institutions.
The document will also provide much-needed clarity around minimal standards, facilitating better research and therefore improving the speed of innovation, as well as robustness. This is especially true for companies such as Axol, who have already invested in working practices that embed quality and reproducibility as standard.
In a technically demanding, fast-paced industry, it’s important to establish a clear framework that instils confidence in stem cell research. And as the drug discovery industry transitions from animal models to in vitro assays, we must look to promote accurate, reproducible data to maximize the potential of this exciting technology.
The ISSCR standards document provides a timely and definitive step in this direction, and we fully support its integration into industry best practices.
Our Compliance Statement
As a company that values consistency, quality and scientific rigor, we have a long-standing history of meeting and exceeding industry best practices. We have also been involved in several areas of foundational work with iPSC and in vitro quality standards.
Our scientists have conducted a thorough analysis of our current processes to match against the ISSCR Standards Document. We are pleased to report excellent compliance with the guidance, and have made our report available to view below.
